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Terminated

ACMI REF E-3F Electrohydraulic Lithotripsy Probe, 3 FR x 120CM

FDA Recall Z-0926-04 · Posted 2004-07-20

Recalling FirmACMI CORPORATION
Recall StatusTerminated
Product CodeFFK
Date Initiated2004-04-30
Date Terminated2005-06-13
Product Quantity541 boxes(3 probes/box)

Reason for Recall

Product sterility may be compromised due to the lack of package seal integrity

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide Foreign: Canada, Australa, Brazil, Korea, Mexico, Turkey

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980492AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)Circon Acmi · 1998-11-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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