Z-1013-2011

VAD Kit Reorder DT8915, Sterile, Centurion Medical Products Corp. Williamston, MI

Name: Z-1013-2011 VAD Kit Reorder DT8915, Sterile, Centurion Medical Products Corp. Williamston, MI
Creator: Centurion Medical Products
Published: 2010-12-06
License: https://open.fda.gov/license/

Centurion Medical Products, LP / initiated 2010-12-06 / Terminated / root cause: manufacturing process

FDA source

Centurion Medical Products began a recall of VAD Kit Reorder DT8915, Sterile, Centurion Medical Products Corp. Williamston, MI Intended use: Vascular access port kit on 2010-12-06. The reason FDA records is "The firm is conducting a recall of kits that contain the MONOJECT PREFILL ADVANCED flush syringes containing heparin. The syringes are under recall by their manufacturer Coviden because of testing that showed "that the...". 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-1013-2011
Status: Terminated
Initiated: 2010-12-06
Posted: 2011-02-01
Terminated: 2011-02-16
Recalling firm: Centurion Medical Products, LP
Product: VAD Kit Reorder DT8915, Sterile, Centurion Medical Products Corp. Williamston, MI Intended use: Vascular access port kit
Product code: LRS I.V. Start Kit
Reason for recall: The firm is conducting a recall of kits that contain the MONOJECT PREFILL ADVANCED flush syringes containing heparin. The syringes are under recall by their manufacturer Coviden because of testing that showed "that the crude heparin used to produce a specific batch of purified heparin sodium USP contained low level of Over-Sulfated Chondroitin Sulfate (OSCS)".
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm, Covidien, sent an "URGENT PRODUCT RECALL" letter dated November 12, 2010, to affected customers via Certified Mail, Return Receipt Requested. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and in-use stock to determine if they have any units of the affected product, if found, immediately remove from inventory and quarantine; if they are a distributor they were ask to notify their customers of this letter; and complete and return the PRODUCT RECALL FORM whether or not they have the affected product via fax to: 203-822-6009 or scan and email to: [email protected]. Note: The returned product will be collected and counted prior to destruction or return to the vendor. Should you have any medical questions concerning this recall, please call 508-261-6393. For Customer Service questions regarding the recall, please use one of the following methods: phone 1-800-962-9888 option 1 (8am to 6:30pm Eastern); email: [email protected] or fax: 302-822-6009.
Quantity in commerce: 80
Distribution: Nationwide Distribution: USA including states of: OH, WI, IL, MO and TX.
Product codes and lots: 2010112950

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)