MEDLINE INDUSTRIES, LP - Northfield - Medline Probe Cover Kits - Class 2 Recall
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP PROCEDURE PACK, Model Number DYNJ67771; c) EP PACK, Model Number DYNJ68019; d) GWINNETT ENDOVASCULAR WSTE MGT, Model Number DYNJ68198; e) TAVR PACK, Model Number DYNJ68499B; f) VEIN CLINIC, Model Number DYNJ68667; g) VASCULAR PACK, Model Number DYNJ68863; h) VASCULAR PACK, Model Number DYNJ68880; i) TAVR PACK, Model Number DYNJ68933; j) PROCEDURE PACK, Model Number DYNJ68968A; k) PORT PACK, Model Number DYNJ68990A; l) STROKE PACK, Model Number DYNJ69009A; m) ENDOVENOUS BASIC PACK, Model Num...
Source: Medical Device Recalls - July 21, 2023 Category: Medical Devices Source Type: alerts
GE Healthcare, LLC - GE Healthcare MR Systems. - Class 2 Recall
GE Healthcare MR Systems. Magnetic Resonance imaging (MRI) can be used to distinguish diseased or compromised tissue from normal tissue. MRI technology is routinely used to help the diagnosis in diseases such as oncology, stroke, heart and peripheral vascular disease, pediatric diseases, etc. (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 22, 2022 Category: Medical Devices Source Type: alerts
Stryker Neurovascular - AXS Vecta 71 Aspiration Catheter - Class 2 Recall
Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459210(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-125, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459227(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 71 Aspiration Catheter, Ref. Catalog No. INC-11129-132, Use By 2021-11-29, Rx Onl...
Source: Medical Device Recalls - April 1, 2020 Category: Medical Devices Source Type: alerts
Stryker Neurovascular - AXS Vecta 74 Aspiration Catheter - Class 2 Recall
Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-115, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459241(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-125, Use By 2021-11-29, Rx Only, Sterile/EO, Manufactured For: Stryker Neurovascular 47900 Bayside Parkway, Fremont, CA 94538, UDI: (01)07613327459258(17)211129(10)00000-00 Stryker Neurovascular, AXS Vecta 74 Aspiration Catheter, Ref. Catalog No. INC-11597-132, Use By 2021-11-29, Rx Onl...
Source: Medical Device Recalls - April 1, 2020 Category: Medical Devices Source Type: alerts
STROKE II SYNERGY Oil [PHYTOPIA CO., LTD.]
Updated Date: Jul 10, 2018 EST (Source: DailyMed Drug Label Updates)
Source: DailyMed Drug Label Updates - July 10, 2018 Category: Drugs & Pharmacology Source Type: alerts
Micro Therapeutics Inc, Dba Ev3 Neurovascular - MINDFRAME CAPTURE(TM) LP Revascularization Device - Class 1 Recall
MindFrame Capture LP Revascularization Devices: Product Numbers: (a) REF 300010 (b) REF 300011 (c) REF 300012 (d) REF 300013 (e) REF 300014 (f) REF 300015 (g) REF 300016 (h) REF 300017 (i) REF 300018 Intended to restore blood flow by removing thrombus from a large intracranial vessel experiencing ischemic stroke within 8 hours of symptom onset. (Source: Medical Device Recalls)
Source: Medical Device Recalls - May 17, 2018 Category: Medical Devices Source Type: alerts
Stryker Neurovascular - Stroke Fast Pack(TM) - Class 2 Recall
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm; UPN M0033PK42022002 Stroke intervention kit (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 6, 2017 Category: Medical Devices Source Type: alerts
Stryker Neurovascular - Stroke Fast Pack(TM) - Class 2 Recall
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 6, 2017 Category: Medical Devices Source Type: alerts
Stryker Neurovascular - Stroke Fast Pack(TM) - Class 2 Recall
Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 Stroke intervention kit (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 6, 2017 Category: Medical Devices Source Type: alerts
Stryker Neurovascular - Stroke Fast Pack(TM) - Class 2 Recall
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2017 Category: Medical Devices Source Type: alerts
Stryker Neurovascular - Stroke Fast Pack(TM) - Class 2 Recall
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M0033PK62523001 ST 150 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2017 Category: Medical Devices Source Type: alerts
Stryker Neurovascular - Stroke Fast Pack(TM) - Class 2 Recall
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK43022001 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2017 Category: Medical Devices Source Type: alerts
Stryker Neurovascular - Stroke Fast Pack(TM) - Class 2 Recall
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001 (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 30, 2017 Category: Medical Devices Source Type: alerts
Penumbra Inc. - Penumbra 3D Revascularization Device - Class 1 Recall
Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. (Source: Medical Device Recalls)
Source: Medical Device Recalls - June 23, 2017 Category: Medical Devices Source Type: alerts
Kingsway Trading Inc. Recalls “ Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement ” because it Contains Banned Ephedra Alkaloids
Kingsway Trading Inc. of Brooklyn, NY is recalling its 1.06 oz (30g) bottles of “ Well Balance Xanthium& Siler Combo (Bi Yan Pian) ” Batch No. 130401& Batch No. 150201 because they contain the presence of undeclared Ephedra Herba (ma huang), an FDA banned item. Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death, and that these risks are unreasonable in light of any benefits that may result from the use of these products under their labeled conditions of use, or under ordinary conditions of use if the labeling is silent. (Source: FDA Food Safety)
Source: FDA Food Safety - February 8, 2017 Category: Food Science Source Type: alerts
