Z-0656-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- November 7, 2019
- Termination Date
- April 23, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,428
Product Description
Ligamax 5 mm Endoscopic Multiple Clip Applier
Reason for Recall
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.
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
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