Z-0770-2007

83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc

Name: Z-0770-2007 83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc
Creator: Custom Ultrasonics, Inc.
Published: 2005-12-12
License: https://open.fda.gov/license/

Wassenburg Medical B.V. / initiated 2005-12-12 / Terminated

FDA source

Custom Ultrasonics, Inc. began a recall of 83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc on 2005-12-12. The reason FDA records is "The device was marketed without a 510k". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0770-2007
Status: Terminated
Initiated: 2005-12-12
Posted: 2007-05-04
Terminated: 2013-02-20
Recalling firm: Wassenburg Medical B.V.
Product: 83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc.
Product code: FEB Accessories, Cleaning, For Endoscope
Reason for recall: The device was marketed without a 510k
FDA root cause: PMA
Action: On 12/12/05, the recalling firm telephoned their sales representatives to inform them of the problem. Letter were hand delivered to the hospitals by the sales representatives.
Quantity in commerce: 4 units
Distribution: Worldwide-The device was shipped to medical facilities in CA, GA, VA. and the UK.
Product codes and lots: Serial numbers: 051305-J, 061705-E, 061605-F, and 061705-G.

Product code FEB

K061430Class IISystem 83 Plus Miniflex Washer-DisinfectorCustom Ultrasonics / cleared 2007-01-12

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)