Recall Z-1076-2015— MAST Biosurgery USA, Inc

Name: FDA recall Z-1076-2015
Creator: U.S. Food and Drug Administration
Published: 2014-08-26

Class II · Terminated

Class II FDA medical device recall by MAST Biosurgery USA, Inc, initiated 2014-08-26, terminated 2015-02-24. It names one FDA 510(k) clearance: K061473. Product: 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.. 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..

Recalling firm: MAST Biosurgery USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-08-26
Terminated: 2015-02-24
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K061473 — SURGI-WRAP MAST BIORESORBABLE SHEETMast Biosurgery USA, Inc.·cleared 2006-09-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.