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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien Kerlix Super Sponge Saline Dressing

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  Class 2 Device Recall Covidien Kerlix Super Sponge Saline Dressing see related information
Date Initiated by Firm March 03, 2017
Date Posted March 27, 2017
Recall Status1 Terminated 3 on October 07, 2019
Recall Number Z-1743-2017
Recall Event ID 76606
Product Classification Dressing,wound,occlusive - Product Code NAD
Product Covidien Kerlix Super Sponge Saline Dressing, Sterile
Item Code: 3338
Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.
Code Information Lot Number beginning with: 14, 15, 16 Expiration Date: From February 2017 through November 2019
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		 Product sterility is compromised due to breach of sterile barrier
FDA Determined
Cause 2		 Packaging process control
Action Medtronic/Covidien) initiated recall by letter on March 3, 2017 via Federal Express. 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. Contact Medtronic representative or Customer Service at (800) 882-5878 For questions regarding this recall call 203-492-5000.
Quantity in Commerce 38794
Distribution Worldwide Distribution. US (Nationwide), Internationally to Canada, Australia, Brunei, Japan, Mexico, Philippines, Singapore, Andorra, Belgium, Botswana, Czech Republic, Denmark, Egypt, France, Greece, Hungary, Ireland, Israel, Italy, Kenya, Libya, Luxembourg, Mauritius, Namibia, Netherlands, Norway, Poland, Portugal, Russia, Russian Federation, Spain, Saudi Arabia, Seychelles, Slovakia, South Africa, Switzerland, UAE, 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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