Recall Z-1707-2010
Angiodynamics, Inc. · initiated May 17, 2010
Product
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.
Codes / lots: Lot Number: 991437.
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.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1707-2010
- Initiated
- May 17, 2010
- Posted by FDA
- May 27, 2010
- Terminated
- July 25, 2012
- Product code
- KRA – Catheter, Continuous Flush
- Quantity
- 20 units
- Distribution
- Worldwide Distribution -- United States (AR, NY, PA, MI, MN, LA and WA), Spain, Austria and Denmark.
- Recalling firm
- Angiodynamics, Inc., Queensbury, NY