Z-1063-2013 Class II Terminated
FDA device recall Z-1063-2013 was initiated by Covidien LP on Feb 11, 2013 and is designated Class II. Reason for recall: Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical… The recall status is terminated (terminated Mar 20, 2014). Affected quantity: 6,751 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 17, 2013
- Initiation Date
- Feb 11, 2013
- Termination Date
- Mar 20, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,751 units
Product Description
Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.
Reason for Recall
Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention
Distribution Pattern
Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.
Code Information
Lot Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1063-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026