Recall Z-1264-2020— COVIDIEN LLC
Class II · Terminated
Class II FDA medical device recall by COVIDIEN LLC, initiated 2020-01-17, terminated 2022-07-29. It names one FDA 510(k) clearance: K111825. Product: Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND. Reason: Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection.
- Recalling firm
- COVIDIEN LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-17
- Terminated
- 2022-07-29
- 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
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Reason for recall
Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
Data sourced from openFDA. This site is unofficial and independent of the FDA.