Recall Z-0656-2019— COVIDIEN LLC
Class II · Terminated
Class II FDA medical device recall by COVIDIEN LLC, initiated 2018-11-05, terminated 2020-08-14. FDA's recall record names no specific 510(k) clearance for this event. Product: 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826. Reason: The product was released into commercial distribution while subject to importation refusal..
- Recalling firm
- COVIDIEN LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-11-05
- Terminated
- 2020-08-14
- Firm location
- Mansfield, MA, United States
Product description
8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
Reason for recall
The product was released into commercial distribution while subject to importation refusal.
Data sourced from openFDA. This site is unofficial and independent of the FDA.