—#161505

Product

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 product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K111825
Affected lot / code info: N7F1058KX, N7F1121KX, N7F1056KX, N7F1057KX

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Covidien LLC
Address: 60 Middletown Ave, North Haven, Connecticut 06473-3908

Distribution

Distribution pattern: Nationally

Timeline

Recall initiated: 2017-09-13
Posted by FDA: 2018-02-16
Terminated: 2019-06-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161505. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.