ARROW INTERNATIONAL Inc. recalls Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic…
Read the official notice →- Date
- 2024-06-12
- Country
- United States
- Brand
- Arrow
- Product
- Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
- Classification
- Class I
- Units
- Worldwide distribution. US nationwide including Puerto Rico, AU, BA, BE, BG,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
More Arrow recalls
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ARROW INTERNATIONAL, LLC recalls Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code: (01)10801902220315(17)261231(11)251210(10)33F25J0347 This device is…
Due to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured
FDA · DeviceARROW INTERNATIONAL, LLCU.S. Nationwide distribution in the states of AZ, CA, GA, MA, ME, MI, OR, PA,…Official notice → - 2024-10-02
- US
ARROW INTERNATIONAL Inc. recalls Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF…
Reports have been received regarding open seals on the packaging.
FDA · DeviceARROW INTERNATIONAL Inc.US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC,…Official notice → - 2024-03-27
- US
ARROW INTERNATIONAL Inc. recalls ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF…
Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire…
FDA · DeviceARROW INTERNATIONAL Inc.Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: AE,…Official notice → - 2023-10-11
- US
ARROW INTERNATIONAL Inc. recalls Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF…
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
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- US
ARROW INTERNATIONAL Inc. recalls Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Other drugs & medical recalls in the United States
- 2024-06-12
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR,…
These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of Canada, Panama.Official notice → - US
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FDA · DeviceCORENTEC CO., LTDUS Nationwide distribution in the states of AL, AZ, CA, MI, PA, TX.Official notice → - US
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Reports of patient burns.
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Zydus Pharmaceuticals (USA) Inc recalls Estradiol Transdermal System, USP (Twice-Weekly) 0.025mg/day, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad,…
Failed Impurities/Degradation Specifications.