Recall Z-1917-2008 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Celsus Laboratories Inc
Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and in vitro diagnostic devices.
| Date | Jul 18, 2008 (initiated Mar 31, 2008) |
| Status | Terminated |
| Reason | Contamination: The firm learned that up to 2.2% oversulfated chondroitin was found in a batch of crude heparin they received from their supplier. |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.