MONOJECT Blood Collection Tubes containing heparin 13x100 sodium heparin trace element Item Code 8881307014
FDA Recall Z-1569-2011 · Posted 2011-03-07
Recalling FirmCovidien LP
Recall StatusTerminated
Product CodeJKA
Date Initiated2010-11-15
Date Terminated2015-12-04
Product Quantity18,100
Reason for Recall
The heparin sodium USP used to manufacture blood collection tubes was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
Firm 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.
Root Cause
Material/Component Contamination
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.