FDAFDA · Food and drugs·Recall number Z-1063-2013
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.
Published April 17, 2013 · Recall initiated: February 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien LP
- Distributor
- Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.
- Lot
- Lot Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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