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Terminated

MONOJECT Blood Collection Tubes containing heparin 10x64 Sodium Heparin Item code 8881320256

FDA Recall Z-1571-2011 · Posted 2011-03-07

Recalling FirmCovidien LP
Recall StatusTerminated
Product CodeJKA
Date Initiated2010-11-15
Date Terminated2015-12-04
Product Quantity126,000

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.

K883320MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBESherwood Medical Co. · 1988-09-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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