Recall Z-1767-2010
Angiodynamics, Inc. · initiated January 8, 2010
Product
DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 55 cm Straight Basic Kit, Catalog Number/REF 10302809, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804
Codes / lots: Lots 981859, 982375, 978919
Reason for recall
The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers were used during the manufacturing 100% leak test.
FDA-determined cause: Other
Action taken
Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.
Details
- Recall number
- Z-1767-2010
- Initiated
- January 8, 2010
- Posted by FDA
- June 4, 2010
- Terminated
- July 25, 2012
- Product code
- MSD – Catheter, Hemodialysis, Implanted
- Quantity
- 174
- Distribution
- Nationwide and St. Thomas, VI
- Recalling firm
- Angiodynamics, Inc., Queensbury, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1761-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 22 cm Straight Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1762-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 24 cm Straight Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1763-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 28 cm Straight Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1764-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 32 cm Straight Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1765-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 36 cm Straight Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1766-2010 | DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 40 cm Straight Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1768-2010 | DURAMAX (TM) Hemodialysis Catheters, Stack Tip 24 cm Pre-Curve Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1769-2010 | DURAMAX (TM) Hemodialysis Catheters, Stack Tip 28 cm Pre-Curve Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1770-2010 | DURAMAX (TM) Hemodialysis Catheters, Stack Tip 32 cm Pre-Curve Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |
| Z-1771-2010 | DURAMAX (TM) Hemodialysis Catheters, Stack Tip 36 cm Pre-Curve Basic Kit, Catalog…The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform… | 01/08/2010Terminated |