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U.S. Department of Health and Human Services

Class 2 Device Recall MONOJECT Blood Collection Tubes containing heparin

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 Class 2 Device Recall MONOJECT Blood Collection Tubes containing heparinsee related information
Date Initiated by FirmNovember 15, 2010
Date PostedMarch 07, 2011
Recall Status1 Terminated 3 on December 04, 2015
Recall NumberZ-1569-2011
Recall Event ID 57314
510(K)NumberK883320 
Product Classification Tubes, vials, systems, serum, separator, blood collection - Product Code JKA
ProductMONOJECT Blood Collection Tubes containing heparin 13x100 sodium heparin trace element Item Code 8881307014
Code Information Lot # 910905
FEI Number 1282497
Recalling Firm/
Manufacturer		 Covidien LP
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact
508-261-8000
Manufacturer Reason
for Recall		The heparin sodium USP used to manufacture blood collection tubes was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.
FDA Determined
Cause 2		Material/Component Contamination
ActionCovidien 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 Commerce18,100
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JKA
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