Z-1917-2008

Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and...

Name: Z-1917-2008 Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and...
Creator: Celsus Laboratories Inc
Published: 2008-03-31
License: https://open.fda.gov/license/

Celsus Laboratories Inc / initiated 2008-03-31 / Terminated / root cause: manufacturing process

FDA source

Celsus Laboratories Inc began a recall of Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and in vitro diagnostic devices on 2008-03-31. The reason FDA records is "Contamination: The firm learned that up to 2.2% oversulfated chondroitin was found in a batch of crude heparin they received from their supplier". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1917-2008
Status: Terminated
Initiated: 2008-03-31
Posted: 2008-07-18
Terminated: 2012-09-21
Recalling firm: Celsus Laboratories Inc
Product: Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin for use in blood collection tube devices and in vitro diagnostic devices.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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.
Root cause tag: manufacturing process
FDA 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 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.
Product codes and lots: Lot# HL-31707, HL-31807, HL-32708, HL-32808 & HL-32908

Product code JKA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)