FMsealer Open Shears recall
FMsealer Open Shears. Model FM3001
Why was FMsealer Open Shears recalled?
Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lots: 153411; 160321; 160531; 160991; 161311; 161442; 161871; 162091
- Product
- FMsealer Open Shears. Model FM3001
- Recalling firm
- Domain Surgical, Inc.
- Quantity
- 70 units US; 175 units OUS
- Distribution
- Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
- Recall date
- December 7, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)