Z-0925-04

ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM

Name: Z-0925-04 ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM
Creator: Acmi Corporation
Published: 2004-04-30
License: https://open.fda.gov/license/

ACMI Corporation / initiated 2004-04-30 / Terminated / root cause: packaging

FDA source

ACMI CORPORATION began a recall of ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM on 2004-04-30. The reason FDA records is "Product sterility may be compromised due to the lack of package seal integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0925-04
Status: Terminated
Initiated: 2004-04-30
Posted: 2004-07-20
Terminated: 2005-06-13
Recalling firm: ACMI Corporation
Product: ACMI REF E-1F Electrohydraulic Lithotripsy Probe, 1.9 FR x 120CM
Product code: FFK Lithotriptor, Electro-Hydraulic
Reason for recall: Product sterility may be compromised due to the lack of package seal integrity
Root cause tag: packaging
FDA 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 in commerce: 1479 boxes (3 probes/box)
Distribution: Nationwide Foreign: Canada, Australa, Brazil, Korea, Mexico, Turkey
Product codes and lots: Lot Numbers: 1122753E to 1283804C

Product code FFK

K980492Class IIAeh-3 Electrohydraulic Lithotripter and Probes (E-1F, E-3F, E-5F, and E-9F)Circon Acmi / cleared 1998-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)