Z-0657-05

ABSOLOK Extra Absorbable Ligating Clip cartridges, large, code AP400. Ten cartridges are packaged per box

Name: Z-0657-05 ABSOLOK Extra Absorbable Ligating Clip cartridges, large, code AP400. Ten cartridges are packaged per box
Creator: Ethicon Endo-Surgery
Published: 2005-02-28
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2005-02-28 / Terminated / root cause: packaging

FDA source

Ethicon Endo-Surgery began a recall of ABSOLOK Extra Absorbable Ligating Clip cartridges, large, code AP400. Ten cartridges are packaged per box on 2005-02-28. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0657-05
Status: Terminated
Initiated: 2005-02-28
Posted: 2005-03-25
Terminated: 2007-02-21
Recalling firm: Ethicon Endo-Surgery Inc
Product: ABSOLOK Extra Absorbable Ligating Clip cartridges, large, code AP400. Ten cartridges are packaged per box.
Product code: FZP Clip, Implantable
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.
Root cause tag: packaging
FDA root cause: Other
Action: The recalling firm sent a letter, dated 2/28/05 to consignees.
Quantity in commerce: 7968 devices.
Distribution: 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.
Product codes and lots: Lot: TE7978, exp. date 01/09; TE8279, exp. date 01/09; TE2018, exp. date 01/09; TG2223, exp. date 01/09; TG7067, exp. date 01/09; TL7643, exp. date 07/09; SK2036, exp. date 07/08; SL2110, exp. date 07/08; SM2078, exp. date 07/08; SM2353, exp. date 07/08; TA7932, exp. date 01/09; TB2334, exp. date 01/09; TE2375, exp. date 01/09; and TE2486, exp. date 01/09.

Product code FZP

K812323Class IIPds* Absorbable Ligating ClipsETHICON, Inc. / cleared 1981-11-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)