Saranas, Inc. recalls Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is…
Read the official notice →- Date
- 2022-09-14
- Country
- United States
- Brand
- Saranas, Inc.
- Product
- Early Bird Bleed Monitoring System Introducer Sheath Set, REF: FG001-01 (6F), FG001-02 (8F)
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of PA, MI, FL, WV, TX, NJ,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
Other drugs & medical recalls in the United States
- 2022-09-14
USAmerican Contract Systems, Inc. recalls Various Angiography packs/trays
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
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Stradis Healthcare recalls VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
Potential for incomplete seals.
- US
Datascope Corporation recalls MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Certain lots containing undersized dilator.
FDA · DeviceDatascope CorporationAwaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech…Official notice → - US
Medline Industries Inc. recalls Medline CHEST TUBE REORDER NO: DYNJ36762A
Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Convenience Kit
FDA · DeviceMedline Industries Inc.U.S. Nationwide distribution in the state of AL.Official notice → - US
ICU Medical, Inc. recalls Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX…
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic…
FDA · DeviceICU Medical, Inc.Worldwide distribution - US Nationwide distribution including in the states of…Official notice → - US
BALT USA, LLC recalls Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.