PFM MEDICAL INC. recalls Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm,
See all recalls from PFM MEDICAL INC. →Recalled Product
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Hazard / Issue
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.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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