Retiro De Equipo (Recall) de Device Recall SurgiWrap

Recall

70051

Class 2

Z-1076-2015

2014-08-26

2015-02-10

Terminated

United States

2015-02-24

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132886

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.

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.