United StatesMulti‑Snare Set devices — 5 mm x 125 cm (REF 147305) and 10 mm x 125 cm (REF 147310) — sold by PFM Medical Inc., were recalled; they can be identified by those size and REF numbers. The devices failed to meet biocompatibility requirements for in‑vitro cytotoxicity, which if in contact with a patient’s vasculature could result in localized inflammation and tissue irritation. The recall covers units distributed in the United States (noted in New York and Maryland).
What's being recalled
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Recalling firm: PFM Medical Inc., Carlsbad, CA, United States.
How to identify it
REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)
The hazard
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of NY, MD.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)