Brennen Skin Graft Mesher. Surgical instrument designed recall
Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
Why was Brennen Skin Graft Mesher. Surgical instrument designed recalled?
Sterilization validation failure.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Code: 131600, 131601, 131602, 131603, 131604, 131500, 131501, 131502, 131503, 131504 and 131506.
- Product
- Brennen Skin Graft Mesher. Surgical instrument designed to expand skin grafts'
- Recalling firm
- Molnlycke Health Care, Inc
- Quantity
- 956 units
- Distribution
- Domestic: U.S. Nationwide; Foreign: Austria, Australia, Bangladesh, Canada, Chile, Germany, Denmark, Finland, France, Great Britain, Hong Kong, Hungary, Ireland, India, Italy, Jordan, Korea, Kuwait, Malaysia, Norway, New Zealand, Peru, Saudi Arabia, Sweden Switzerland, Taiwan, Turkey, South Africa, United Arab Emirates.
- Recall date
- May 24, 2017
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)