Z-1078-2011

Centurion Medical Products V.A.D. Tray HT1995A, Sterile

Name: Z-1078-2011 Centurion Medical Products V.A.D. Tray HT1995A, Sterile
Creator: Centurion Medical Products
Published: 2010-06-02
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2010-06-02 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products began a recall of Centurion Medical Products V.A.D. Tray HT1995A, Sterile on 2010-06-02. The reason FDA records is "The kits contain heparin lock flush solution USP code 504505 that is under recall by APP Pharmaceuticals. APP Pharmaceuticals is recalling the heparin because of incomplete documentation associated with test results". 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-1078-2011
Status: Terminated
Initiated: 2010-06-02
Posted: 2011-02-09
Terminated: 2011-02-09
Recalling firm: Centurion Medical Products, LP
Product: Centurion Medical Products V.A.D. Tray HT1995A, Sterile.
Product code: LRS I.V. Start Kit
Reason for recall: The kits contain heparin lock flush solution USP code 504505 that is under recall by APP Pharmaceuticals. APP Pharmaceuticals is recalling the heparin because of incomplete documentation associated with test results.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Centurion Medical Products sent out Urgent Product Recall Notices on 6/3/2010. A second recall notice was sent to nonresponding consignees on 6/21/2010. The letter instructed the consignees to quarantine the recalled product and contact Centurion so that the recalled product can be retrieved.
Quantity in commerce: 180
Distribution: Nationwide distribution.
Product codes and lots: 2009102950

Product code LRS

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