Z-0495-2022 Class II Terminated
FDA device recall Z-0495-2022 was initiated by Covidien Llc on December 6, 2021 and is designated Class II. Reason for recall: Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for … The recall status is terminated (terminated May 11, 2023). Affected quantity: 504 devices.
Recall Details
- Product Type
- Devices
- Report Date
- January 19, 2022
- Initiation Date
- December 6, 2021
- Termination Date
- May 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 504 devices
Product Description
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Reason for Recall
Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained.
Distribution Pattern
Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution.
Code Information
UDI: 20884521705880 10884521705883; Lot Number: 11320187X