Recall Z-0636-2018— Covidien LLC
Class II · Terminated
Class II FDA medical device recall by Covidien LLC, initiated 2017-09-13, terminated 2019-06-28. It names one FDA 510(k) clearance: K111825. Product: Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.. Reason: Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time..
- Recalling firm
- Covidien LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-13
- Terminated
- 2019-06-28
- Firm location
- North Haven, CT, 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
Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Reason for recall
Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
Data sourced from openFDA. This site is unofficial and independent of the FDA.