Device product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-2203A; 3) ECONO STERILE WEITLANER RETR BL 3X4 5.5"CS25, Model Numbers: 96-2207A; 4) ECONO STERILE WEITLANER RETR SH 3X4 5.5"CS25, Model Numbers: 96-2208A; 5) ECONO STERILE WEITLANER RETR 3X4 SH 8" CS/10, Model Numbers: 96-2209A; 6) ECONO STERILE WEITLANER RETR 3X4 BL 8" CS/10 , Model Numbers: 96-2210A; 7) ECONO STERILE HOLZHEIMER RETR 4PRG SH 4"CS25, Model Numbers: 96-2241A; 8) ECONO STERILE HOLZHEIMER RETR 4PRG BL 4"CS25, Model Numbers: 96-2242A; surgical retractor
Z-0929-2025
Product summary
- Event
- Event 95946
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 75 units
- Official record key
device-enforcement:Z-0929-2025
Official wording
Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.
Code information: 1) 96-2201A, UDI/DI 50649111493100, Lot Codes: SK-120; 2) 96-2203A, UDI/DI 50649111493094, Lot Codes: SK-120; 3) 96-2207A, UDI/DI 50649111493117, Lot Codes: SK-120; 4) 96-2208A, UDI/DI 50649111493124, Lot Codes: SK-120 5) 96-2209A, UDI/DI 50649111493155, Lot Codes: SK-120; 6) 96-2210A, UDI/DI 50649111493162, Lot Codes: SK-130; 7) 96-2241A, UDI/DI 50649111492820, Lot Codes: SK-115; 8) 96-2242A, UDI/DI 50649111492837, Lot Codes: SK-115;
Distribution pattern: Domestic: Nationwide Distribution
Derived failure modes
-
Sterility assurance
breach of the sterile barrier