Z-1601-2008

Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe 5mL REF # 8881590125, Tyco Healthcare...

Name: Z-1601-2008 Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe 5mL REF # 8881590125, Tyco Healthcare...
Creator: Covidien LP
Published: 2008-03-28
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-03-28 / Terminated / root cause: manufacturing process

FDA source

Covidien LP began a recall of Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe 5mL REF # 8881590125, Tyco Healthcare, Mansfield, MA 02048 on 2008-03-28. The reason FDA records is "Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant". 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-1601-2008
Status: Terminated
Initiated: 2008-03-28
Posted: 2008-05-09
Terminated: 2012-06-25
Recalling firm: Medtronic, Inc.
Product: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe 5mL REF # 8881590125, Tyco Healthcare, Mansfield, MA 02048
Product code: NZW Heparin, Vascular Access Flush
Reason for recall: Scientific Protein Laboratories (SPL), disclosed that two lots of Heparin Sodium, USP Active Pharmaceutical Ingredient has a heparin-like contaminant
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Tyco Healthcar notifed customers by letter sent via US Postal Service beginning 3/28/08, through 4/1/08. The letter requests that they immediately stop using and return the product. Distributors are requested to in-turn notify their customers. An instruction sheet was attached for product return and replacement. All customers are required to respond to the notice regardless of remaining inventory. .
Quantity in commerce: 7,959,224 units
Distribution: Nationwide Distribution
Product codes and lots: Lot Numbers: 7041194; 7102804; 7041204; 7113034; 7051534; 7113044; 7051544; 7113054; 7051554 ; 7113104; 7071924 ; 7113114; 7072034; 7113154; 7072044; 8010064; 7072054; 8010114; 7072064 ; 8010134; 7072154; 8010174; 7082284;

Product code NZW

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)