ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401819, CATHETER SIZE 4F, CATHETER LENGTH 90
FDA device recall Z-3267-2011 · posted 2011-09-19 · Terminated
Recall details
- Recalling firm
- Angiodynamics Worldwide Headquarters
- Reason for recall
- The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 24 units
- Distribution
- Worldwide Distribution -- USA and The Netherlands.
- Date initiated
- 2011-01-28
- Date posted
- 2011-09-19
- Date terminated
- 2012-10-18
- Location
- Latham, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PULSE*SPRAY INFUSION SYSTEM (K951509) | Angiodynamics, Div. E-Z-Em, Inc. | 1995-06-16 |