Device product
8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
Z-0656-2019
Product summary
- Firm
- COVIDIEN LLC
- Event
- Event 81607
- Status
- Terminated
- Classification
- Class II
- Quantity
- 32,071 units
- Official record key
device-enforcement:Z-0656-2019
Official wording
Reason: The product was released into commercial distribution while subject to importation refusal.
Code information: Lot Number 1816211264
Distribution pattern: The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
Derived failure modes
-
Unknown
The product was released into commercial distribution while subject to importation refusal.