Recall Z-1707-2010 ยท KRA Catheter, Continuous Flush
Angiodynamics, Inc.
PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERILE, EO. AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804. Infusion Catheter.
| Date | May 27, 2010 (initiated May 17, 2010) |
| Status | Terminated |
| Reason | This lot was packaged with the wrong occluding ball guidewire. The PulseSpray Catheter is 90 cm in length and requires a 109 cm occluding ball guidewire, however this lot was packaged with a 60 cm occluding ball guidewire. |
| Root cause | Process control |
| Action | Angiodynamics issued an "Urgent Medical Device Recall" notification (dated 5/11/10) to user accounts via Certified Mail. Consignees were asked to identify, segregate and return all affected product to the firm in addition to sending in a completed Reply Form via fax. For further information, contact Angiodynamics Customer Service at 1-800-772-6446. |
| Quantity | 20 units |
| Distribution | Worldwide Distribution -- United States (AR, NY, PA, MI, MN, LA and WA), Spain, Austria and Denmark. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905447 | E-Z-EM PULSED INFUSION SYSTEM E-Z-Em, Inc., Apr 1, 1991 |