Recall Z-1409-2017 ยท MMP Cover, Barrier, Protective
Covidien LLC
Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 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 | 42,750 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 |