MAST Biosurgery Recalls SurgiWrap Film Due to Expiration Date Mismatch
MAST Biosurgery is recalling 49 units of SurgiWrap Bioresorbable Adhesion Barrier Film because the expiration date on the barcode did not match the printed date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a documentation and labeling issue involving a mismatch in expiration dates. There are no reported injuries, illnesses, or functional defects in the product itself, which aligns with the criteria for a Low severity recall.
Plain-English summary
MAST Biosurgery USA, Inc. is recalling 49 pieces of SurgiWrap Bioresorbable Adhesion Barrier Film, specifically the 100x130x0.05mm size. The affected product is identified by Lot 52804 and was distributed worldwide to China.
The recall was initiated because the expiration date on the barcode of the envelope label did not match the expiration date printed next to the hourglass symbol. The printed expiration date was August 2017, while the barcode date read July 31, 2017. The correct expiration date for the product is July 31, 2017.
Consumers and healthcare facilities should stop using the affected product and contact MAST Biosurgery USA, Inc. for further instructions or a return.
The recalled product
- 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.
- Manufacturer
- MAST Biosurgery USA, Inc
- Category
- Medical Device — Surgical Film
- Hazard
- Affected units
- 49
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LOT 52804 2017-08
Distribution
Distribution scope not specified by the agency.
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