FDA Medical Device Recalls (openFDA)
Clark Research and Development Inc: Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 100mL, Clark Research and Development, Inc. Folsom, LA 70437
- Recall number
- Z-0551-2007
- Recalling firm
- Clark Research and Development Inc
- Product
- Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 100mL, Clark Research and Development, Inc. Folsom, LA 70437
- Status
- Terminated
- Initiated
- 2007-01-19
- Posted
- 2007-02-28
- Terminated
- 2007-07-17
- Reason
- Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions
- 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
- 1
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot numbers 564 though 577
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FLD
- Firm FEI
- 2316506
- Firm city
- Folsom
- Firm state
- LA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28