Covidien LP: MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 5 ml in 12 ml syringe Item code 8881590125

Recall number

Z-0569-2011

Recalling firm

Covidien LP

Product

MONOJECT Prefill Heparin Lock Flush Syringe 100 Unit Heparin, 5 ml in 12 ml syringe Item code 8881590125

Status

Terminated

Initiated

2010-11-15

Posted

2010-12-09

Terminated

2015-12-04

Reason

The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.

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 adfeedback@coviden.com following the instructions on the form. For questions customers were to contact Customer Service at 1-800-962-9888

Quantity

1,539,540

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

Lot, serial or model codes

Lot # 9082104, 9082114, 9082154, 9092164

510(k) numbers

["K032438"]

PMA numbers

not on file

Product code

NGT

Firm FEI

1282497

Firm city

Mansfield

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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