Z-1569-2011

MONOJECT Blood Collection Tubes containing heparin 13x100 sodium heparin trace element Item Code 8881307014

Name: Z-1569-2011 MONOJECT Blood Collection Tubes containing heparin 13x100 sodium heparin trace element Item Code 8881307014
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 Blood Collection Tubes containing heparin 13x100 sodium heparin trace element Item Code 8881307014 on 2010-11-15. The reason FDA records is "The heparin sodium USP used to manufacture blood collection tubes 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-1569-2011
Status: Terminated
Initiated: 2010-11-15
Posted: 2011-03-07
Terminated: 2015-12-04
Recalling firm: Medtronic, Inc.
Product: MONOJECT Blood Collection Tubes containing heparin 13x100 sodium heparin trace element Item Code 8881307014
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: The heparin sodium USP used to manufacture blood collection tubes was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Covidien 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 immediately stop using the product, and return it to the firm. Distributors were instructed to notify their customers. All customers were required to respond to the notice regardless of their remaining inventory. Responses will be tracked for follow-up and effectiveness checks. For Customers Service questions regarding this recall call 1-800-962-9888 option 1.
Quantity in commerce: 18,100
Distribution: Worldwide Distribution - USA including AL, AZ, CA, CO, DE, FL, GA, IA, ID, IL, KS, KY, MA, MI, MN, MO, MS, NC, ND, NE, NJ, NM, MV, MY, OH, OK, PA, SC, SD, TN, TX, WA, and WI and the country of Canada
Product codes and lots: Lot # 910905

Product code JKA

K883320Class IIMonoject(r) Trace Element Blood Collection TubeSherwood Medical Co. / cleared 1988-09-27

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)