Z-1575-2009

Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code...

Name: Z-1575-2009 Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code...
Creator: Tri-State Hospital Supply Corporation
Published: 2008-04-08
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2008-04-08 / Terminated / root cause: manufacturing process

FDA source

Tri-State Hospital Supply Corporation began a recall of Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder KNV50. Each tray contains 1 sterile heparin... on 2008-04-08. The reason FDA records is "The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination". 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-1575-2009
Status: Terminated
Initiated: 2008-04-08
Posted: 2009-07-07
Terminated: 2009-11-19
Recalling firm: Centurion Medical Products, LP
Product: Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder KNV50. Each tray contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125.
Product code: OKE Port Introducer Kit
Reason for recall: The kits contain Monoject prefill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Tri State Hospital notified their consignees by letter dated 4/8/08 and instructed to discontinue use of the product and to either discard or return it.
Quantity in commerce: 460 trays
Distribution: Indiana, Mississippi, Ohio and Tennessee.
Product codes and lots: Tray lots 801148, 801158 and 811127. Heparin flush lots 7072064 and 7082284.

Product code OKE

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)