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Terminated

TLS2 Thermal Ligating Shears, Catalog Number 132-131D

FDA Recall Z-1698-2019 · Posted None

Recalling FirmMicroline Surgical, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2019-03-22
Date Terminated2020-07-30
Product Quantity115 units

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.

Firm Action

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

Root Cause

Under Investigation by firm

Distribution Pattern

The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K062257STARION INSTRUMENTS THERMAL LITIGATING SHEARSStarion Instruments · 2006-10-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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