TLS2 Thermal Ligating Shears, Catalog Number 132-131D
This recall has been terminated (originally issued March 22, 2019).
- Company
- Microline Surgical, Inc.
- Recall Initiated
- March 22, 2019
- Terminated
- July 30, 2020
- Recall Number
- Z-1698-2019
- Quantity
- 115 units
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.
Lot / Code Info
UDI: 811099011439; Lot Numbers: 807118, 807119, 807120, 811076
Root Cause
Under Investigation by firm
Action Taken
Urgent Medical Device Recall letters dated 3/22/19 were sent to customers.
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