Recall Z-0742-2018 ยท DQO Catheter, Intravascular, Diagnostic
Angiodynamics, Inc.
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
| Date | Feb 13, 2018 (initiated Sep 22, 2017) |
| Status | Terminated |
| Reason | Product was placed into distribution prior to completion of all required post sterilization release activities. |
| Root cause | Process control |
| Action | Consignees were contacted by phone and by a letter sent via Federal Express. Consignees were instructed to stop using product, segregate affected product, and return the product to the firm along with a reply verification tracking form. For further questions, please call (518) 795-1676. |
| Quantity | 28 |
| Distribution | US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112452 | ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS AngioDynamics, Inc., Mar 30, 2012 |