FDA Recall Terminated

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.

Recall: Z-1076-2015 · Initiated August 26, 2014

Recall

Recall Number: Z-1076-2015
Event Number: 70051
Firm: MAST Biosurgery USA, Inc
FEI Number: 3004661493
Product Code: FTL
Status: Terminated
Root Cause: Labeling Change Control
Initiated: August 26, 2014
Posted: February 10, 2015
Terminated: February 24, 2015
Address: 6749 Top Gun St, Ste 108, San Diego, CA, 92121-4151

Description

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.

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 and the IFU into the newly labeled envelopes that they provide documentation that the product had been repackaged into the new envelopes. The distributor was also requested to verify that they did not ship any product to customers with the incorrect label. The firm had the distributor return the 49 improperly with the incorrect labels and the first set of "corrected" labels to them for destruction. Further questions call (858) 550-8050.

Distribution

Worldwide Distribution to the country of China.

Quantity

49 pieces