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Terminated

ABSOLOK Extra Absorbable Ligating Clip cartridges, medium/large, code AP300. Ten cartridges are packaged per box.

FDA Recall Z-0656-05 · Posted 2005-03-25

Recalling FirmEthicon Endo-Surgery
Recall StatusTerminated
Product CodeFZP
Date Initiated2005-02-28
Date Terminated2007-02-21
Product Quantity15,462 boxes.

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.

K812323PDS* ABSORBABLE LIGATING CLIPSETHICON, Inc. · 1981-11-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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