PULSESPRAY INFUSION SYSTEM, 90 cm x 20 cm infusion length, Catalog No./Ref 12500402, STERILE, EO. AngioDynamics, 603 Que
FDA device recall Z-1707-2010 · posted 2010-05-27 · Terminated
Recall details
- Recalling firm
- Angiodynamics, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 20 units
- Distribution
- Worldwide Distribution -- United States (AR, NY, PA, MI, MN, LA and WA), Spain, Austria and Denmark.
- Date initiated
- 2010-05-17
- Date posted
- 2010-05-27
- Date terminated
- 2012-07-25
- 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 |
|---|---|---|
| E-Z-EM PULSED INFUSION SYSTEM (K905447) | E-Z-Em, Inc. | 1991-04-01 |