FDA-Device2019-12-18Class II
Ligamax 5 mm Endoscopic Multiple Clip Applier
Ethicon Endo-Surgery Inc
Hazard
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.
Sold states
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
Affected count
48,428
Manufactured in
4545 Creek Rd, N/A, Blue Ash, OH, United States
Products
Ligamax 5 mm Endoscopic Multiple Clip Applier
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0656-2020Don't want to check this manually?
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