ABSOLOK Extra Absorbable Ligating Clip cartridges, large, code AP400. Ten cartridges are packaged per box.
FDA Recall Z-0657-05 · Posted 2005-03-25
Recalling FirmEthicon Endo-Surgery
Recall StatusTerminated
Product CodeFZP
Date Initiated2005-02-28
Date Terminated2007-02-21
Product Quantity7968 devices.
Reason for Recall
The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.
Firm Action
The recalling firm sent a letter, dated 2/28/05 to consignees.
Root Cause
Other
Distribution Pattern
The product was distributed throughout the United States and to foreign customers located in Saudi Arabia, Egypt, United Kingdom, Germany, France, Republic of Panama, Turkey, Hong Kong, Taiwan, Puerto Rico, Spain, Japan, China, Republic of Singapore, Argentina, Italy, New Zealand, Australia, Canada, Czech Republic, Sweden, Portugal, Slovenia, Poland, Hungary, and the United Arab Emirate.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.