Date Initiated by Firm |
January 10, 2007 |
Date Posted |
January 30, 2007 |
Recall Status1 |
Completed |
Recall Number |
Z-0359-2007 |
Recall Event ID |
36990 |
510(K)Number |
K003323
|
Product Classification |
Hernia Patch - Product Code FTL
|
Product |
Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 0010202 |
Code Information |
Recalled Lot Numbers: 43AOD 43LOD 43BOD 43APD 43COD 43BPD 43DOD 43CPD 43EOD 43DPD 43FOD 43EPD 43GOD 43FPD 43HOD 43GPD 43IOD 43HPD 43JOD 43IPD 43KOD; Market Wthdrawal Lot Numbers: 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 |
32,581 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.
|