Device product
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning
Z-0925-2025
Product summary
- Event
- Event 95946
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 25 units
- Official record key
device-enforcement:Z-0925-2025
Official wording
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Code information: 1) 96-2273, UDI/DI 50649111448735, Lot Codes: SK-129; 2) 96-2283, UDI/DI 50649111448780, Lot Codes: SK-129
Distribution pattern: Domestic: Nationwide Distribution
Derived failure modes
-
Sterility assurance
breach of the sterile barrier