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Terminated

Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL, Clark Research and Development, Inc. Folsom, LA 70437

FDA Recall Z-0553-2007 · Posted 2007-02-28

Recalling FirmClark Research and Development Inc
Recall StatusTerminated
Product CodeFLD
Date Initiated2007-01-19
Date Terminated2007-07-17
Product Quantity276

Reason for Recall

Lack of sterility assurance based on lack of sterility validation for labeled sterilization directions

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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