Recall Z-0928-04 ยท FFK Lithotriptor, Electro-Hydraulic
ACMI CORPORATION
ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM
| Date | Jul 20, 2004 (initiated Apr 30, 2004) |
| Status | Terminated |
| Reason | Product sterility may be compromised due to the lack of package seal integrity |
| Root cause | Other |
| Action | ACMI issued a recall letter dated 4/30/04 via Certified Mail. Users will be asked to return unused product. International Distributors were faxed letters notifying of them of the action. |
| Quantity | 951 boxes(6 probes/box) |
| Distribution | Nationwide Foreign: Canada, Australa, Brazil, Korea, Mexico, Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980492 | AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) Circon Acmi, Nov 17, 1998 |