Recall Z-0495-2022— Covidien Llc
Class II · Terminated
Class II FDA medical device recall by Covidien Llc, initiated 2021-12-06, terminated 2023-05-11. It names one FDA 510(k) clearance: K162941. Product: LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837. Reason: 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..
- Recalling firm
- Covidien Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-12-06
- Terminated
- 2023-05-11
- Firm location
- Mansfield, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.