Class 2 Device Recall Lithium Heparin

• Date Initiated by Firm: March 31, 2008
• Date Posted: July 18, 2008
• Recall Status: Terminated 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
• FEI Number: 1527761
• 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: 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.