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Terminated

Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

FDA Recall Z-0636-2018 · Posted 2018-02-16

Recalling FirmCovidien LLC
Recall StatusTerminated
Product CodeGDW
Date Initiated2017-09-13
Date Terminated2019-06-28
Product Quantity3,816

Reason for Recall

Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.

Firm Action

All consignees were notified via Federal Express or certified mail on September 13, 2017, and the letter informs customers of the potential for failure of the device safety interlock and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. All in control inventory and product returned from customers will be scrapped.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationally

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111825ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERSCovidien, Formerly US Surgical A Divison of Tyco H · 2011-10-25

Official Source

View FDA Recall →

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

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