Ligamax 5 mm Endoscopic Multiple Clip Applier recall: Sterility Concern
Ligamax 5 mm Endoscopic Multiple Clip Applier
Why was Ligamax 5 mm Endoscopic Multiple Clip Applier recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Ligamax 5 mm Endoscopic Multiple Clip Applier
- Recalling firm
- Ethicon Endo-Surgery Inc
- Quantity
- 48,428
- Distribution
- 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
- Recall date
- December 18, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)