FDA-Device2015-02-18Class II

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.

MAST Biosurgery USA, Inc
Hazard

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.

Sold states
Worldwide Distribution to the country of China.
Affected count
49 pieces
Manufactured in
6749 Top Gun St Ste 108, N/A, San Diego, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1076-2015

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