Recall Z-0656-2019 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
COVIDIEN LLC
8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve), Model Number 36826
| Date | Nov 5, 2018 |
| Status | Terminated |
| Reason | The product was released into commercial distribution while subject to importation refusal. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall letters dated 11/5/18 were sent to customers. |
| Quantity | 32,071 units |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.