TLS2 Thermal Ligating Shears recall
TLS2 Thermal Ligating Shears, Catalog Number 132-131D
Why was TLS2 Thermal Ligating Shears recalled?
The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.
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?
UDI: 811099011439; Lot Numbers: 807118, 807119, 807120, 811076
- Product
- TLS2 Thermal Ligating Shears, Catalog Number 132-131D
- Recalling firm
- Microline Surgical, Inc.
- Quantity
- 115 units
- Distribution
- The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.
- Recall date
- June 12, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)