Recall Z-2226-2008 ยท EYB Catheter, Ureteral, Gastro-Urology
Gyrus ACMI Corporation
Gyrus ACMI 10 Fr. Dual Lumen Catheter Reference Number: 608 BX (Box of 5) and 608 (single unit) This product has multiple uses, including ureteral dilation, anesthetic injection, stone displacement, contrast injection, and safety wire / guidewire placement. The "ACMI" Dual Lumen Catheter is a radiopaque ureteral catheter.
| Date | Sep 16, 2008 (initiated Jun 25, 2008) |
| Status | Terminated |
| Reason | Particulate matter in the catheter |
| Root cause | Process control |
| Action | Gyrus initiated a recall by letter dated 6/ 25 /08. An updated letter issued July 9, 2008 which supersedes the previous letter. The July 9th letter updates the lot numbers affected in the recall. A reply form request was sent to consignees informing them of the problem and asking them to obtain a RMA and return the product. They are also requested to FAX back a reply form so that the response can be tracked. For assistance, please contact Gyrus ACMI at 1-888-524-7266. |
| Quantity | 6820 units |
| Distribution | Nationwide Foreign: Canada, UK, Netherlands, Spain, Italy, Sweden, France, Portugal, Ireland, , Brazil, Australia, South Africa, and Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043581 | DUAL LUMEN CATHETER Acmi Corporation, Mar 3, 2005 |