Oscor Inc. recalls Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart…
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
Read the official notice →- Date
- 2026-07-22
- Country
- United States
- Brand
- Oscor
- Product
- Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart…
- Classification
- Class I
- Units
- Distribution in the US state of MA
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Oscor recalls
- 2022-02-23
USOscor Inc. recalls Destino Twist 14F (also branded as Guidestar 14F)
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
FDA · DeviceOscor Inc.Distribution to TN and PA in USA OUS distribution to Czech RepublicOfficial notice →
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Abiomed, Inc. recalls ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart…
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr…
FDA · DeviceAbiomed, Inc.Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium…Official notice → - US
CareFusion 213, LLC recalls BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL)…
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- US
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