Z-0495-2022 Class II Terminated
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