Z-1625-2012

50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE...

Name: Z-1625-2012 50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE...
Creator: Meddev USA, Inc.
Published: 2012-05-10
License: https://open.fda.gov/license/

Meddev USA, Inc. / initiated 2012-05-10 / Terminated / root cause: sterility

FDA source

MEDDEV USA, INC. began a recall of 50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE MEDDEV USA, INC. 100 Highland Park Village/Suite 200... on 2012-05-10. The reason FDA records is "The device was marketed without a 510(k) and is not sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1625-2012
Status: Terminated
Initiated: 2012-05-10
Posted: 2012-05-17
Terminated: 2013-08-15
Recalling firm: Meddev USA, Inc.
Product: 50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE MEDDEV USA, INC. 100 Highland Park Village/Suite 200 DALLAS, TEXAS 75205 For use in humans. No indication of use is on the label. However, the device can be used for infusion.
Product code: KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Reason for recall: The device was marketed without a 510(k) and is not sterile.
Root cause tag: sterility
FDA root cause: No Marketing Application
Action: MEDDEV USA, Inc decided to recall and notified their customer by phone on 05/10/12. Customers were instructed to return the entire shipment to MEDDEV . For questions regarding this recall call 214-692-3559.
Quantity in commerce: 20 units
Distribution: Nationwide Distribution including Illinois
Product codes and lots: Lot 120493

Product code KDH

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)