Z-0565-2011

MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 3 ml in 12 ml syringe Item code 8881580123

Name: Z-0565-2011 MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 3 ml in 12 ml syringe Item code 8881580123
Creator: Covidien LP
Published: 2010-11-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2010-11-15 / Terminated / root cause: manufacturing process

FDA source

Covidien LP began a recall of MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 3 ml in 12 ml syringe Item code 8881580123 on 2010-11-15. The reason FDA records is "The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate". 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-0565-2011
Status: Terminated
Initiated: 2010-11-15
Posted: 2010-12-09
Terminated: 2015-12-04
Recalling firm: Medtronic, Inc.
Product: MONOJECT Prefill Heparin Lock Flush Syringe 10 Unit Heparin, 3 ml in 12 ml syringe Item code 8881580123
Product code: NGT Saline, Vascular Access Flush
Reason for recall: The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: COVIDEN sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and in-use stock to determine if they had any units of the affected product and quarantine the product immediately. Distributors were instructed to notify their customers immediately of the URGENT PRODUCT RECALL letter. Customers were to fill out the enclosed response form and return it by fax to (203) 822-6009 or email to [email protected] following the instructions on the form. For questions customers were to contact Customer Service at 1-800-962-9888
Quantity in commerce: 329,520
Distribution: Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, LA, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and Bermuda
Product codes and lots: Lot # 90181964

Product code NGT

K032438Class IIModification to: Monojet Prefill 0.9% Sodium Chloride Flush Syringe, Monojet Prefill Heprin Lock Flush SyringeTyco Healthcare / cleared 2004-06-30

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)