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: 490 units Lot/code info: Catalog Number: KIT-051-01, UDI-DI code: 00841268106130 Lot Numbers: 24298473 24190504 INT-101-15, UDI-DI code: 00841268107380 Lot Number: 24284447
00841268106130, 00841268107380
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.