Recall Z-1743-2017 ยท NAD Dressing, Wound, Occlusive
Covidien LLC
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.
| Date | Mar 27, 2017 (initiated Mar 3, 2017) |
| Status | Terminated |
| Reason | Product sterility is compromised due to breach of sterile barrier |
| Root cause | 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 | 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, Norwa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.