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Recall Observatory FDA recall evidence

Device 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.

Z-1076-2015

August 26, 2014

Class II

Product summary

Firm
MAST Biosurgery USA, Inc
Event
Event 70051
Status
Terminated
Classification
Class II
Quantity
49 pieces
Official record key
device-enforcement:Z-1076-2015

Official wording

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.

Code information: LOT 52804 2017-08

Distribution pattern: Worldwide Distribution to the country of China.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.