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U.S. Department of Health and Human Services

Class 2 Device Recall ABSOLOK Extra Absorbable Ligating Clip cartridges, large, code AP400.

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 Class 2 Device Recall ABSOLOK Extra Absorbable Ligating Clip cartridges, large, code AP400.see related information
Date Initiated by FirmFebruary 28, 2005
Date PostedMarch 25, 2005
Recall Status1 Terminated 3 on February 21, 2007
Recall NumberZ-0657-05
Recall Event ID 31351
510(K)NumberK812323 
Product Classification Clip, Implantable - Product Code FZP
ProductABSOLOK Extra Absorbable Ligating Clip cartridges, large, code AP400. Ten cartridges are packaged per box.
Code Information 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.
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information ContactCarol 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
ActionThe recalling firm sent a letter, dated 2/28/05 to consignees.
Quantity in Commerce7968 devices.
DistributionThe 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 CycleTPLC 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) Database510(K)s with Product Code = FZP
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