Recall Z-1854-2016 ยท LRS I.V. Start Kit
Covidien LLC
Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522
| Date | May 31, 2016 (initiated Mar 3, 2016) |
| Status | Terminated |
| Reason | Compromised sterility due to breach of barrier |
| Root cause | 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 | 3152197 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.