Z-1383-2021 Class II Terminated
FDA device recall Z-1383-2021 was initiated by Covidien, LP on March 4, 2021 and is designated Class II. Reason for recall: Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty sing… The recall status is terminated (terminated July 12, 2024). Affected quantity: 5928 units WW: 4212 US 1716 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- April 21, 2021
- Initiation Date
- March 4, 2021
- Termination Date
- July 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5928 units WW: 4212 US 1716 OUS
Product Description
Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
Reason for Recall
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.
Code Information
Lot Numbers: N0A1038UY N0E0016UY N0F0616UY N0K0934UY N0B0493UY N0F0254UY N0F0817UY N0M0334UY N0C0436UY N0F0518UY N0G0388UY N9K1095UY N0D0731UY N0F0615UY N0J0859UY N9L0797UY UDI: 10884521741843 20884521741840