Ligamax 5 mm Endoscopic Multiple Clip Applier
Reported: December 18, 2019 Initiated: November 7, 2019 #Z-0656-2020
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.
Details
- Recalling Firm
- Ethicon Endo-Surgery Inc
- Units Affected
- 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
- Location
- Blue Ash, OH
Frequently Asked Questions
What product was recalled? ▼
Ligamax 5 mm Endoscopic Multiple Clip Applier. Recalled by Ethicon Endo-Surgery Inc. Units affected: 48,428.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0656-2020.
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