Recall Z-1408-2017 ยท MMP Cover, Barrier, Protective
Covidien LLC
Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures
| Date | Jan 23, 2017 |
| Status | Terminated |
| Reason | Sterility compromised due to breach in sterile barrier |
| Root cause | Packaging process control |
| Action | Medtronic issued recall letter on January 23, 2017. Customers were notified via Federal Express and the letter instructed customers to discontinue use of the product and return all inventory to Medtronic (Covidien) 195 McDermott Road, North Haven, CT 06473 Attn: Field Returns Department. |
| Quantity | 1,111,600 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041501 | GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS Guangzhou Fortunique , Ltd., Nov 30, 2004 |