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U.S. Department of Health and Human Services

Class 2 Device Recall ABSOLOK Extra Absorbable Ligating Clip cartridges, small, code AP100.

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  Class 2 Device Recall ABSOLOK Extra Absorbable Ligating Clip cartridges, small, code AP100. see related information
Date Initiated by Firm February 28, 2005
Date Posted March 25, 2005
Recall Status1 Terminated 3 on February 21, 2007
Recall Number Z-0654-05
Recall Event ID 31351
510(K)Number K812323  
Product Classification Clip, Implantable - Product Code FZP
Product ABSOLOK Extra Absorbable Ligating Clip cartridges, small, code AP100. Ten cartridges are packaged per box.
Code Information Lot: SL2102, exp. date 07/08; SL2116, exp. date 07/08; SL2123, exp. date 07/08; SM7266, exp. date 07/08; SP2618, exp. date 07/08; TB2043, exp. date 01/09; TB2044, exp. date 01/09; TB2199, exp. date 01/09; TB2333, exp. date 01/09; TB7971, exp. date 01/09; TD7873, exp. date 01/09; TG8166, exp. date 01/09; TJ2047, exp. date 07/09; TJ2331, exp. date 07/09; TJ8306, exp. date 07/09; TK8398, exp. date 07/09; TL2243, exp. date 07/09; TL2352, exp. date 07/09; and TP7672, exp. date 07/09.
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information Contact Carol Montandon
513-337-3419
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action The recalling firm sent a letter, dated 2/28/05 to consignees.
Quantity in Commerce 10,470 boxes.
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FZP and Original Applicant = ETHICON, INC.
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