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U.S. Department of Health and Human Services

Class 1 Device Recall Davol Composix Kugel Hernia Patch

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  Class 1 Device Recall Davol Composix Kugel Hernia Patch see related information
Date Initiated by Firm January 10, 2007
Date Posted January 30, 2007
Recall Status1 Completed
Recall Number Z-0360-2007
Recall Event ID 36990
510(K)Number K003323  
Product Classification Hernia Patch - Product Code FTL
Product Bard Composix Kugel Hernia Patch-
Large Circle 4.5'' with ePTFE
Product Code: 0010204
Code Information Lot Numbers: 43AOD 43LOD  43BOD 43APD  43COD 43BPD  43DOD 43CPD  43EOD 43DPD  43FOD 43EPD  43GOD 43FPD  43HOD 43GPD  43IOD 43HPD 43JOD 43IPD  43KOD; Market Withdrawal: 43JPD 43DQD  43KPD 43EQD  43LPD 43FQD 43AQD 43GQD  43BQD 43HQD  43CQD 43IQD* *Redesigned products will be clearly indicated on the  label. Any product of this lot with the word 'Redesigned' on the label is not part of this Market Withdrawal.
Recalling Firm/
Manufacturer		 Davol, Inc., Sub. C. R. Bard, Inc.
100 Sockanossett Crossroad
Cranston RI 02920
For Additional Information Contact Robin Drago
401-463-7000
Manufacturer Reason
for Recall		 PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula
FDA Determined
Cause 2		 Other
Action Davol Inc. notified Hospital Administrators/Risk Health Managers,distributors, and surgeons of the expanded recall by letter beginning 1/10/07. Product under recall is to be returned to Davol for replacement. Davol is posting recall information to their website.
Quantity in Commerce 16,603 units
Distribution Nationwide
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.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = DAVOL, INC.
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