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Terminated

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 Recall Z-1707-2010 · Posted 2010-05-27

Recalling FirmAngiodynamics, Inc.
Recall StatusTerminated
Product CodeKRA
Date Initiated2010-05-17
Date Terminated2012-07-25
Product Quantity20 units

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution -- United States (AR, NY, PA, MI, MN, LA and WA), Spain, Austria and Denmark.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K905447E-Z-EM PULSED INFUSION SYSTEME-Z-Em, Inc. · 1991-04-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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