Z-0553-2007

Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL...

Name: Z-0553-2007 Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL...
Creator: Clark Research and Development Inc
Published: 2007-01-19
License: https://open.fda.gov/license/

Clark Research and Development, Inc. / initiated 2007-01-19 / Terminated / root cause: labeling and UDI

FDA source

Clark Research and Development Inc began a recall of Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL, Clark Research and Development, Inc. Folsom, LA 70437 on 2007-01-19. The reason FDA records is "Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0553-2007
Status: Terminated
Initiated: 2007-01-19
Posted: 2007-02-28
Terminated: 2007-07-17
Recalling firm: Clark Research and Development, Inc.
Product: Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL, Clark Research and Development, Inc. Folsom, LA 70437
Product code: FLD Apparatus, Hemoperfusion, Sorbent
Reason for recall: Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm notified its consignees of the problem and the recall via letter (priority mail with delivery confirmation)dated 01/19/2007 beginning on 01/19/2007. This letter requested that the consignee cease the use of this product and contact the recalling firm for return instructions. Follow-up with non-reponders will be made by facsimile.
Quantity in commerce: 276
Distribution: Nationwide
Product codes and lots: Lot numbers 564 though 577

Product code FLD

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)