Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
This recall has been terminated (originally issued February 16, 2018).
- Company
- Covidien Llc
- Recall Initiated
- September 13, 2017
- Posted
- February 16, 2018
- Terminated
- June 28, 2019
- Recall Number
- Z-0636-2018
- Quantity
- 3,816
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
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.
Distribution
Nationally
Lot / Code Info
N7F1058KX, N7F1121KX, N7F1056KX, N7F1057KX
Root Cause
Under Investigation by firm
Action Taken
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.
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