Arrow International Inc recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous…
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
Read the official notice →- Date
- 2021-11-24
- Country
- United States
- Brand
- Arrow
- Product
- Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous…
- Classification
- Class I
- Units
- Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: BE…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-09-27
USARROW 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 → - 2022-12-21
- US
ARROW INTERNATIONAL Inc. recalls Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- US
ARROW INTERNATIONAL Inc. recalls Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d)…
There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable…
FDA · DeviceARROW INTERNATIONAL Inc.US Distributor in states of: FL, GA, KY, OH, PA and WV.Official notice → - 2022-10-26
- US
ARROW INTERNATIONAL Inc. recalls ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For…
Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for…
FDA · DeviceARROW INTERNATIONAL Inc.US Nationwide distribution in the state of Florida.Official notice → - 2022-07-06
- US
ARROW INTERNATIONAL Inc. recalls Arrow Three-Lumen CVC
Gravity flow rates on the affected product lidstock are incorrect.
FDA · DeviceARROW INTERNATIONAL Inc.US Nationwide distribution in the states of Florida.Official notice →
Other drugs & medical recalls in the United States
- 2021-11-24
- US
bioMerieux, Inc. recalls API 50 CH, Model 50300
There is potential to provide an incorrect organism identification.
- US
OmniLife Science recalls OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total…
The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
- US
Bio-Rad Laboratories, Inc. recalls BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is…
Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation…
FDA · DeviceBio-Rad Laboratories, Inc.Worldwide Distribution: U.S.(nationwide) including states of: AK, AL, AZ, CA,…Official notice → - US
Beaver Visitec International, Inc. recalls bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent…
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
FDA · DeviceBeaver Visitec International, Inc.Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan…Official notice → - US
Siemens Medical Solutions USA, Inc recalls Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641…
System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances,…
- US
Scrip Inc recalls Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination.