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TLS2 Thermal Ligating Shears, Catalog Number 132-131D recallZ-1698-2019 · Microline Surgical, Inc. · initiated Mar 22, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Microline Surgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Under Investigation by firm

What the company is doing

Urgent Medical Device Recall letters dated 3/22/19 were sent to customers.

Recall details

Recall number
Z-1698-2019
Status
Terminated
Initiated by the company
Mar 22, 2019
Recalling firm
Microline Surgical, Inc.
Quantity
115 units
Product code
GEI
FDA submissions
K062257
Distribution
The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.

Product description

TLS2 Thermal Ligating Shears, Catalog Number 132-131D

Code information (models, lots, serial numbers)

UDI: 811099011439; Lot Numbers: 807118, 807119, 807120, 811076

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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