Recalls / —
—#91638
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.
- FDA product code
- KRA — Catheter, Continuous Flush
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K905447
- Affected lot / code info
- Lot Number: 991437.
Why it was recalled
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 (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Angiodynamics, Inc.
- Address
- 603 Queensbury Avenue, Queensbury, New York 12804
Distribution
- Distribution pattern
- Worldwide Distribution -- United States (AR, NY, PA, MI, MN, LA and WA), Spain, Austria and Denmark.
Timeline
- Recall initiated
- 2010-05-17
- Posted by FDA
- 2010-05-27
- Terminated
- 2012-07-25
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #91638. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.