Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 Angi
FDA device recall Z-0742-2018 · posted 2018-02-13 · Terminated
Recall details
- Recalling firm
- Angiodynamics, Inc.
- Reason for recall
- Product was placed into distribution prior to completion of all required post sterilization release activities.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 28
- Distribution
- US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.
- Date initiated
- 2017-09-22
- Date posted
- 2018-02-13
- Date terminated
- 2018-09-19
- Location
- Queensbury, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS (K112452) | AngioDynamics, Inc. | 2012-03-30 |