Z-3267-2011

ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401819, CATHETER SIZE 4F, CATHETER...

Name: Z-3267-2011 ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401819, CATHETER SIZE 4F, CATHETER...
Creator: Angiodynamics Worldwide Headquarters
Published: 2011-01-28
License: https://open.fda.gov/license/

Angiodynamics Worldwide Headquarters / initiated 2011-01-28 / Terminated / root cause: manufacturing process

FDA source

Angiodynamics Worldwide Headquarters began a recall of ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401819, CATHETER SIZE 4F, CATHETER LENGTH 90 cm, INFUSION LENGTH 20 cm, OCCLUSION... on 2011-01-28. The reason FDA records is "The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3267-2011
Status: Terminated
Initiated: 2011-01-28
Posted: 2011-09-19
Terminated: 2012-10-18
Recalling firm: Angiodynamics Worldwide Headquarters
Product: ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401819, CATHETER SIZE 4F, CATHETER LENGTH 90 cm, INFUSION LENGTH 20 cm, OCCLUSION WIRE SIZE .035 in., STERILE, AngioDynamics Inc., 603 Queensbury Avenue, Queensbury, NY 12804
Product code: KRA Catheter, Continuous Flush
Reason for recall: The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/28/11) and Recall Reply Forms were sent to the consignees via Certified Mail, Return Receipt Requested. The letters identified the scope of the recall, the reason for the recall, the status, and action to be taken. Customers were to identify and segregate the recalled lot in their possession. They were also to complete and fax back the Reply Form. The recalled product should be returned along with a copy of the Reply Form. Replacement product would be shipped upon receipt and confirmation of the returned product. Questions or concerns should be directed towards customers' local sales representative or call Julie Blair, Customer Service Manager at 1-800-772-6446.
Quantity in commerce: 24 units
Distribution: Worldwide Distribution -- USA and The Netherlands.
Product codes and lots: Lot 521372 (Use By 2013-07)

Product code KRA

K951509Class IIPulse*spray Infusion SystemAngiodynamics, Div. E-Z-Em, Inc. / cleared 1995-06-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)