Due to a potential open seal in the sterile barrier packaging .
Reason for recall: Due to a potential open seal in the sterile barrier packaging . Distribution: Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom. Quantity: 2,881 catheters Lot/code info: Catalog Number: DRC-002-05 UDI-DI codes: 00841268100381 Lot Number: 25051843 Catalog Number: DRC-002-06 UDI-DI code: 00841268100398 Lot Number: 25034783
00841268100381, 00841268100398
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.