Z-0701-2007

SCANLAN International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog #1001-761, Lot...

Name: Z-0701-2007 SCANLAN International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog #1001-761, Lot...
Creator: Scanlan International Inc
Published: 2007-02-19
License: https://open.fda.gov/license/

Scanlan International Inc / initiated 2007-02-19 / Terminated / root cause: manufacturing process

FDA source

Scanlan International Inc began a recall of SCANLAN International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog #1001-761, Lot AZ115806 on 2007-02-19. The reason FDA records is "Incorrectly assembled by manufacturer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0701-2007
Status: Terminated
Initiated: 2007-02-19
Posted: 2007-04-03
Terminated: 2007-06-27
Recalling firm: Scanlan International Inc
Product: SCANLAN International Mobin-Uddin Vein Holder, Sterile, Disposable, single-use, catalog #1001-761, Lot AZ115806.
Product code: KDC Instrument, Surgical, Disposable
Reason for recall: Incorrectly assembled by manufacturer
Root cause tag: manufacturing process
FDA root cause: Other
Action: The consignees were notified of the product recall by letter dated February 19, 2007. Consignees were asked to return product to the manufacturer and replacement product is being offered.
Quantity in commerce: 35 units domestically ( 70 units to OUS)
Distribution: Worldwide distribution --- USA including states of IN, MO and country of Japan
Product codes and lots: Lot AZ115806.

Product code KDC

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)