Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall MONOJECT Blood Collection Tubes containing heparin

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall MONOJECT Blood Collection Tubes containing heparin see related information
Date Initiated by Firm November 15, 2010
Date Posted March 07, 2011
Recall Status1 Terminated 3 on December 04, 2015
Recall Number Z-1571-2011
Recall Event ID 57314
510(K)Number K883320  
Product Classification Tubes, vials, systems, serum, separator, blood collection - Product Code JKA
Product MONOJECT Blood Collection Tubes containing heparin
10x64 Sodium Heparin
Item code 8881320256
Code Information Lot # 914803 Lot # 920402
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
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 126,000
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
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JKA and Original Applicant = SHERWOOD MEDICAL CO.
-
-