Medline Industries Inc - Medline Silicone Foley catheter - Class 2 Recall
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2020 Category: Medical Devices Source Type: alerts

Medline Industries Inc - Medline Silicone Foley catheter - Class 2 Recall
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2020 Category: Medical Devices Source Type: alerts

Medline Industries Inc - Medline Silicone Foley catheter - Class 2 Recall
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2020 Category: Medical Devices Source Type: alerts

Medtronic Navigation, Inc. - StealthStation DBS Software Nexframe AutoRegistration - Class 1 Recall
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation) procedure. Neurological stereotaxic Instrument. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 19, 2020 Category: Medical Devices Source Type: alerts

Applied Medical Resources Corp - Vascular Clip - Class 2 Recall
STEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2020 Category: Medical Devices Source Type: alerts

Applied Medical Resources Corp - Vascular Clip - Class 2 Recall
STEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2020 Category: Medical Devices Source Type: alerts

Applied Medical Resources Corp - Vascular Clip - Class 2 Recall
STEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2020 Category: Medical Devices Source Type: alerts

Applied Medical Resources Corp - Vascular Clip - Class 2 Recall
STEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product Usage: The device is indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2020 Category: Medical Devices Source Type: alerts

Medline Industries Inc - Medline convenience kits containing - Class 2 Recall
Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PACK DYNJ30056J ARTHRO/SHOULDER PACK DYNJ30056K ARTHRO/SHOULDER PACK DYNJ30056L ARTHRO/SHOULDER PACK DYNJ30056M BODY PACK DYNJ55107A BODY PACK DYNJ55107C BODY PACK DYNJ55107D C SECTION CDS CDS984613D C SECTION CDS CDS830172I C SECTION CDS CDS984613F C SECTION CDS CDS830172J C SECTION PACK CMPJ17294I C SECTION PACK-LF DYNJ64834 CARDIAC A & B SJ PACK DY...
Source: Medical Device Recalls - May 16, 2020 Category: Medical Devices Source Type: alerts

Pega Medical Inc. - SLIM Handle - Class 3 Recall
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2020 Category: Medical Devices Source Type: alerts

Advanced Bionics, LLC - HiResolution Bionic Ear System - Class 2 Recall
AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2020 Category: Medical Devices Source Type: alerts

Advanced Bionics, LLC - HiResolution Bionic Ear System - Class 2 Recall
AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 16, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 14 cm, LAV, Expanded Kit - Class 2 Recall
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41411-25 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Ra Medical Systems, Inc. - DABRA Laser System (DABRA Laser Model RA308 and DABRA Catheter Model 101) - Class 2 Recall
Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 18-090400-094, USE BY: 2019-09-24, MFR DATE: 2018-09-24, CE, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Revised Label: Product Label - Ra Medical Systems DABRA Catheter 5F (1.5mm), REF: 1222-5000-01, LOT: 19-092400-041, USE BY: 2019-12-13, MFR DATE: 2019-10-14, CE 2797, Laser Radiation, STERILE (Gamma Sterilized), Single Use Only Package Label - DABRA 101 5 French, Ref: 1222-5000-01, Lot: LOT: 19-092400-041, USE BY: 2019-12-13, UDI's (01)00842362100031, (17)20191213(21)2019092400041 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Genicon, Inc. - Genicon EZee Retrieval bag - Class 2 Recall
Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device is disposable and is packaged and sterilized for single use only. The bag may be used for multiple specimen retraction. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 20 cm, LAV, Expanded Kit - Class 2 Recall
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-25. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 20 cm, PMAP, Expanded Kit - Class 2 Recall
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-23. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 20 cm, MAP, Basic Kit - Class 2 Recall
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - Central Venous Catheter, Heparin Coated, 2 Lumen, 16/16 G, 20 cm, PMAP, Expanded Kit - Class 2 Recall
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41406-23 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - TriOx ScvO2 Central Venous Oximetry Catheter, Heparin Coated, Expanded Kit - Class 2 Recall
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Inpeco S.A. - Inpeco SA - Class 2 Recall
Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

ICU Medical, Inc. - Central Venous Catheter, Heparin Coated, 3 Lumen, 16/18/18 G, 30 cm, PMAP, Expanded Kit - Class 2 Recall
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Inpeco S.A. - Inpeco SA - Class 2 Recall
Abbott Accelerator a3600, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: ACP-208-00 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Covidien Llc - Class 2 Recall
Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Covidien Llc - Class 2 Recall
Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Covidien Llc - Class 2 Recall
Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Covidien Llc - Class 2 Recall
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code P4P16XTSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Covidien Llc - Class 2 Recall
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P14TSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Covidien Llc - Class 2 Recall
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Covidien Llc - Class 2 Recall
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P18XTS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Covidien Llc - Class 2 Recall
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Covidien Llc - Class 2 Recall
Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P16TSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Covidien Llc - Class 2 Recall
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P16XTSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Covidien Llc - Class 2 Recall
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P18XTSD - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Access Scientific LLC - Safety Introducer - Class 2 Recall
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Access Scientific LLC - Safety Introducer - Class 2 Recall
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Access Scientific LLC - Safety Introducer - Class 2 Recall
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 94106/10859821006176 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Access Scientific LLC - Safety Introducer - Class 2 Recall
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Access Scientific LLC - Safety Introducer - Class 2 Recall
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/10859821006190 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Access Scientific LLC - Safety Introducer - Class 2 Recall
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit. REF/UDI / 94107/10859821006206 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Access Scientific LLC - Safety Introducer - Class 2 Recall
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Access Scientific LLC - Safety Introducer - Class 2 Recall
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Access Scientific LLC - Safety Introducer - Class 2 Recall
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit. REF/UDI / 94123/10859821006473 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Access Scientific LLC - Safety Introducer - Class 2 Recall
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Access Scientific LLC - Safety Introducer - Class 2 Recall
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit. REF/UDI / 94114/10859821006220 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Access Scientific LLC - Safety Introducer - Class 2 Recall
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/10859821006251 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 15, 2020 Category: Medical Devices Source Type: alerts

Becton, Dickinson and Company, BD Biosciences - CD45 APCH7 - Class 2 Recall
Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-1157-1-01 (OUS); 641399/641399-4012-1-01 (US Research Use Only) - Product Usage: CD45 is intended for in vitro diagnostic use in the identification of cells expressing the CD45 antigen, using a BD FAC brand flow cytometer. The flow cytometer must be equipped to detect light scatter and the appropriate fluorescence, and be equipped with appropriate software (such as BD CellQuest, BD CellQuest Pro, BD FACSDiva, or BD FACSCanto clinical software) for data acquisition and analysis. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 14, 2020 Category: Medical Devices Source Type: alerts

The Magstim Company Limited - Rapid2 - Class 2 Recall
Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 14, 2020 Category: Medical Devices Source Type: alerts

BD SWITZERLAND SARL - BD PCEA Administration Set - Class 2 Recall
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be pr...
Source: Medical Device Recalls - May 14, 2020 Category: Medical Devices Source Type: alerts

BD SWITZERLAND SARL - BD Alaris PCEA Administration Set - Class 2 Recall
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gra...
Source: Medical Device Recalls - May 14, 2020 Category: Medical Devices Source Type: alerts