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U.S. Department of Health and Human Services

Class 2 Device Recall Kerlix" XRay Detectable Laparotomy Sponges

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  Class 2 Device Recall Kerlix" XRay Detectable Laparotomy Sponges see related information
Date Initiated by Firm March 03, 2016
Date Posted May 31, 2016
Recall Status1 Terminated 3 on June 15, 2017
Recall Number Z-1848-2016
Recall Event ID 73427
Product Classification Kit, i.V. Start - Product Code LRS
Product Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 16" x 17" (40.6 cm x 43.2 cm)
Item Number: 4034
Code Information All lots beginning with 110000142862 through lot 130002191062X
Recalling Firm/
Manufacturer		 Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Same
203-492-5000
Manufacturer Reason
for Recall		 Compromised sterility due to breach of barrier
FDA Determined
Cause 2		 Packaging process control
Action Covidien initiated recall by letter on March 4, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Any questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878
Quantity in Commerce 114720
Distribution Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion, New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden and United Kingdom.
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.
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