Recalls / —
—#161576
Product
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.
- FDA product code
- DQO — Catheter, Intravascular, Diagnostic
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K112452
- Affected lot / code info
- Lot Number: 5229642; Manufactured 6-Sep-17; Expiration Date: 31-Aug-20
Why it was recalled
Product was placed into distribution prior to completion of all required post sterilization release activities.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Angiodynamics, Inc.
- Address
- 603 Queensbury Ave, Queensbury, New York 12804-7619
Distribution
- Distribution pattern
- US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.
Timeline
- Recall initiated
- 2017-09-22
- Posted by FDA
- 2018-02-13
- Terminated
- 2018-09-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #161576. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.