Device product
Ligamax 5 mm Endoscopic Multiple Clip Applier
Z-0656-2020
Product summary
- Event
- Event 84280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48,428
- Official record key
device-enforcement:Z-0656-2020
Official wording
Reason: A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in the Tyvek lidding which could result in a breach of sterility.
Code information: Product Code: 11EL5ML Lot Numbers: T93X4R, T93X9D, T93Y2Z, T93Y70, T93Y96, T93Z52, T93Z76, T9401C, T9408F, T94118, T9416M, T9422K, T9426Z, T94402, T94536, T94567, T9461M, T94667, T94721, T94758, T94807, T9484Y, T9487J, T9491A T94A9K, T94C2Z, T94C8N, T94D2N, T94E66, T94F3C, T94F7F, T94G99 T94H1N, T94H78
Distribution pattern: US: Nationwide International: ARGENTINA ARUBA AUSTRALIA AUSTRIA BELGIUM BRAZIL CANADA CHINA COLOMBIA DENMARK ESTONIA FINLAND FRANCE GERMANY INDIA INDONESIA IRELAND JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS NEW CALEDONIA NEW ZEALAND PANAMA PHILIPPINES PUERTO RICO QATAR SAUDI ARABIA SINGAPORE SLOVENIA SWEDEN SWITZERLAND TAIWAN UK
Derived failure modes
-
Sterility assurance
breach of sterility