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U.S. Department of Health and Human Services

Class 2 Device Recall SurgiWrap

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  Class 2 Device Recall SurgiWrap see related information
Date Initiated by Firm August 26, 2014
Date Posted February 10, 2015
Recall Status1 Terminated 3 on February 24, 2015
Recall Number Z-1076-2015
Recall Event ID 70051
510(K)Number K061473  
Product Classification Mesh, surgical, polymeric - Product Code FTL
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.
Code Information LOT 52804 2017-08
Recalling Firm/
Manufacturer		 MAST Biosurgery USA, Inc
6749 Top Gun St Ste 108
San Diego CA 92121-4151
For Additional Information Contact
858-550-8050
Manufacturer 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.
FDA Determined
Cause 2		 Labeling Change Control
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.
Quantity in Commerce 49 pieces
Distribution Worldwide Distribution to the country of China.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = MAST BIOSURGERY USA INC.
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