INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50 (Titanium Dioxide And Zinc Oxide) Lotion [DARPHIN DIST.]
Updated Date: Aug 1, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - August 1, 2017 Category: Drugs & Pharmacology Source Type: alerts
Merge Healthcare, Inc. - Merge Eye Care PACS Viewer 5.2 - Class 2 Recall
Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS is a software solution for the display, management, archive, interface and integration of ophthalmic device reports, images and data. Merge Eye Care PACS is a software solution using databases for patient demographics, server and other systems of intercommunication with hospital systems via HL7 and DICOM to provide to clinicians a single image viewing and management solution of images imported from various contributing devices throughout the clinical environment. Merge Eye Care PACS provides the ability to review data from any network-connected computer, and is protected ...
Source: Medical Device Recalls - July 11, 2017 Category: Medical Devices Source Type: alerts
Arjo, Inc. dba ArjoHuntleigh - ArjoHuntleigh Flowtron ACS900 - Class 2 Recall
ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff. The system is intended for use only in professional healthcare facilities. It is not intended to be used in the home healthcare environment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 27, 2017 Category: Medical Devices Source Type: alerts
MEANINGFUL BEAUTY CINDY CRAWFORD ENVIRONMENTAL PROTECTING MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN (Avobenzone, Homosalate, Octisalate, And Oxybenzone) Cream [Guthy-Renker LLC]
Updated Date: Jun 23, 2017 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - June 23, 2017 Category: Drugs & Pharmacology Source Type: alerts
Acumedia Manufacturers, Inc. - Acumedia Palcam Supplement - Class 2 Recall
Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 15, 2017 Category: Medical Devices Source Type: alerts
KCI USA, INC. - Negative Pressure Wound Therapy Systems - Class 2 Recall
1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). The InfoV.A.C. and V.A.C.ULTA Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, and extended and care settings. They are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include chronic, acute, traumatic, subacute, and dehisced wounds, par...
Source: Medical Device Recalls - May 31, 2017 Category: Medical Devices Source Type: alerts
Del Mar Reynolds Medical, Ltd. - Arkon Anesthesia Delivery System - Class 2 Recall
Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 17, 2017 Category: Medical Devices Source Type: alerts
Roche Diagnostics Corporation - cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer - Class 2 Recall
Sample probes associated with: cobas 6000 Series System, cobas 8000 Modular Analyzer Series, cobas c 311 analyzer cobas c 501/502 cobas c 701/702 cobas 8000 ISE Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyzer Ser...
Source: Medical Device Recalls - May 10, 2017 Category: Medical Devices Source Type: alerts
Siemens Healthcare Diagnostics Inc - RAPIDPoint 500 Blood Gas Analyzer - Class 2 Recall
RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. Siemens SMN numbers: 10492730, 10696857, 10697306 (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 6, 2017 Category: Medical Equipment Source Type: alerts
Breg Inc - Dressing Shldr - Class 2 Recall
Dressing Shldr, P/N 04908 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 3, 2017 Category: Medical Equipment Source Type: alerts
Breg Inc - Dressing Knee/Shldr - Class 2 Recall
Dressing Knee/Shldr, P/N 02328 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 3, 2017 Category: Medical Equipment Source Type: alerts
Breg Inc - If Hip, Sterile Polar Dressing - Class 2 Recall
If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 3, 2017 Category: Medical Equipment Source Type: alerts
Breg Inc - Dressing Shldr XL - Class 2 Recall
Dressing Shldr XL, P/N 04918 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 3, 2017 Category: Medical Equipment Source Type: alerts
Breg Inc - Dressing Rect L - Class 2 Recall
Dressing Rect L, P/N 02428 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 3, 2017 Category: Medical Equipment Source Type: alerts
Breg Inc - Dressing, Knee L/XL - Class 2 Recall
Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 3, 2017 Category: Medical Equipment Source Type: alerts
