Recall Z-0256-04 ยท DYB Introducer, Catheter
Arrow International Inc
Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable (Product # AP-06042) [NB: titanium port]. Product # AP-06042 kit contains 1 low profile implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), injection needle, syringe, tunneling in
| Date | Jul 20, 2004 (initiated Nov 4, 2003) |
| Status | Terminated |
| Reason | The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided. |
| Root cause | Other |
| Action | The firm began notification of consignees via U.S. mail on 11/4/03. A notice of the recall was also posted on the firm''s website (search for 'recall'). |
| Quantity | 913 |
| Distribution | Product was distributed internationally (France, Germany, Mexico, United Kingdom, Singapore, Brazil, Australia) and domestically. Domestic distribution was concentrated in the Midwest and Eastern portions of the US. Total direct accounts : Distributors/dealers, international - 7 Distributors/d |
| FDA record | Open on fda.gov |