Recall Z-1076-2015 ยท FTL Mesh, Surgical, Polymeric
MAST Biosurgery USA, Inc
The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm (01) 18964050255027 (17) 170731(10)52804 LOT 52804 2017-08 REF25502-01 Product is wrapped in a foil pouch that is then sealed into an additional envelope.
| Date | Feb 10, 2015 (initiated Aug 26, 2014) |
| Status | Terminated |
| Reason | The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. The printed expiration date was August of 2017, while the bar code date read as July 31, 2017. The correct expiration date was July 31, 2017. |
| Root cause | Labeling Change Control |
| Action | MAST Biosurgery labeled 49 new envelopes and sent them to the distributor, and subsequently had the distributor remove the contents of the outer envelope (instructions for use and the foil pouches containing the product) and place them into the newly supplied and properly labeled outer envelopes provided by them. The distributor requested to send back the original 49 enveloped. The second batch of new labels was inspected and attached to the new outer envelope to create a properly labeled outer envelope prior to shipping. The firm requested that once the distributor replaced the product an |
| Quantity | 49 pieces |
| Distribution | Worldwide Distribution to the country of China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061473 | SURGI-WRAP MAST BIORESORBABLE SHEET Mast Biosurgery USA, Inc., Sep 21, 2006 |