ACMI REF E-9F Electrohydraulic Lithotripsy Probe, 9 FR x 60CM
FDA device recall Z-0928-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- ACMI CORPORATION
- Reason for recall
- Product sterility may be compromised due to the lack of package seal integrity
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FFK
- Quantity affected
- 951 boxes(6 probes/box)
- Distribution
- Nationwide Foreign: Canada, Australa, Brazil, Korea, Mexico, Turkey
- Date initiated
- 2004-04-30
- Date posted
- 2004-07-20
- Date terminated
- 2005-06-13
- Location
- Southborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F) (K980492) | Circon Acmi | 1998-11-17 |