CLASS II Device recall · Reported 18 Feb 2015 · FDA Enforcement Report
The SurgiWrap Bioresorbable Adhesion Barrier Film recalled
Mast Biosurgery USA is recalling The SurgiWrap Bioresorbable Adhesion Barrier Film. The recall was initiated on 26 Aug 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1076-2015
- FDA event ID
- 70051
- Recalling firm
- Mast Biosurgery USA, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Aug 2014
- FDA classified
- 10 Feb 2015
- Reported
- 18 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Masks, Gloves & PPE
Timeline
| 26 Aug 2014 | Recall initiated by company | |
| 10 Feb 2015 | Classified by FDA | +168 days |
| 18 Feb 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution to the country of China.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
LOT 52804 2017-08
Where was it sold?
Worldwide Distribution to the country of China.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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