Device product
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
Z-2526-2026
Product summary
- Firm
- PFM MEDICAL INC.
- Event
- Event 98942
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32
- Official record key
device-enforcement:Z-2526-2026
Official wording
Reason: 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.
Code information: REF/UDI-DI/Lot(Expiration): 147305/04042301061829/1049868(10/14/2028); 147310/04042301033567/1049960(10/20/28)
Distribution pattern: US Nationwide distribution in the states of NY, MD.
Derived failure modes
-
Foreign material or chemical contamination
foreign body