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U.S. Department of Health and Human Services

Class 2 Device Recall Barrier Hip Sheet with Side Pockets

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 Class 2 Device Recall Barrier Hip Sheet with Side Pocketssee related information
Date Initiated by FirmJuly 14, 2003
Date PostedAugust 14, 2003
Recall Status1 Terminated 3 on November 10, 2003
Recall NumberZ-1137-03
Recall Event ID 26694
510(K)NumberK780282 
Product Classification Drape, Surgical, Antimicrobial - Product Code KKX
ProductBarrier Hip Sheet with Side Pockets
Code Information Product Code 0202 Lot numbers 03149759 and 03165584. Product Code 0204 Lot numbers 030305, 030321, and 03165583. Product Code 9202 Lot numbers 250203, 03205562, and 03255432.
FEI Number 2523357
Recalling Firm/
Manufacturer		 Molnlycke Health Care Inc
826 Newtown-Yardley Road
Newton, Pa PA 18940
For Additional Information ContactKim Harding
267-685-2078
Manufacturer Reason
for Recall		pouch may tear which could result in contamination of sterile field
FDA Determined
Cause 2		Other
ActionThe recalling firm issued recall letters dated 7/9/03 to their direct accounts informing them of the problem/reason for recall, the need to return the product and to contact their customers regarding the recall.
Quantity in Commerce2714 units
DistributionThe products were shipped to distributors, hospitals, and sales representatives nationwide. The product was also shipped to dealers in Australia, New Zealand, Canada, and Belgium.
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 = KKX
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