ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401818, CATHETER SIZE 4F, CATHETER LENGTH 90 cm, INFUSION LENGTH 10 cm, OCCLUSION WIRE SIZE .035 in., STERILE, AngioDynamics Inc., 603 Queensbury Avenue, Queensbury, NY 12804
Hazard
The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires.
What You Should Do
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.
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Products
- Brand
- Angiodynamics Worldwide Headquarters
- UPC
- Lot 521388 (Use By 2013-07)
Units Affected
23 units