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…
Read the official notice →- Date
- 2024-03-27
- Country
- United States
- Brand
- Arrow
- Product
- ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF…
- Classification
- Class I
- Units
- Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: AE,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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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USARROW 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 → - 2024-06-12
- US
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…
FDA · DeviceARROW INTERNATIONAL Inc.Worldwide distribution. US nationwide including Puerto Rico, AU, BA, BE, BG,…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.
- 2023-09-27
- 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.
- 2023-06-28
- US
ARROW INTERNATIONAL Inc. recalls ARROW Endurance Extended Dwell Peripheral Catheter System
Potential for catheter separation or leakage
FDA · DeviceARROW INTERNATIONAL Inc.Nationwide distribution. International distribution to Canada.Official notice →
Other drugs & medical recalls in the United States
- 2024-03-27
- US
Beckman Coulter, Inc. recalls Access Total T4, REF 33800, IVD, thyroxine reagent assay.
Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide, including Puerto Rico and the…Official notice → - US
Thoratec Corp. recalls HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption…
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
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Smiths Medical ASD Inc. recalls smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This…
FDA · DeviceSmiths Medical ASD Inc.Worldwide distribution: US (nationwide) and OUS countries of: Algeria,…Official notice → - US
Super Chill Products recalls Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York,…
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
- US
Hikma Pharmaceuticals USA Inc. recalls Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ…
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
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Eugia US LLC recalls Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown…
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