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U.S. Department of Health and Human Services

Class 2 Device Recall Lithium Heparin

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  Class 2 Device Recall Lithium Heparin see related information
Date Initiated by Firm March 31, 2008
Date Posted July 18, 2008
Recall Status1 Terminated 3 on September 21, 2012
Recall Number Z-1917-2008
Recall Event ID 48084
Product Classification Lithium Heparin - Product Code JKA
Product Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and in vitro diagnostic devices.
Code Information Lot# HL-31707, HL-31807, HL-32708, HL-32808 & HL-32908
Recalling Firm/
Manufacturer		 Celsus Laboratories Inc
12150 Best Pl
Cincinnati OH 45241-1569
For Additional Information Contact Alan Cardin
513-772-8130
Manufacturer Reason
for Recall		 Contamination: The firm learned that up to 2.2% oversulfated chondroitin was found in a batch of crude heparin they received from their supplier.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Celsus notified their customers by e-mail on April 24, 2008, explaining that oversulfated chondroitin was found in a batch of crude heparin they received from their supplier. Celsus recommended the device manufacturers quarantine material from the specified lots.
Quantity in Commerce HL-31707=11,542g, HL-31807=12,836g, HL-32708=8,374g, HL-32808=12,128g & HL-32908=5,000g
Distribution Worldwide Distribution. The Lithium Heparin was sold to companies in USA (Nebraska, New Jersey, Ohio), Puerto Rico, Austria, and Denmark.
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.
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