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Terminated

ThromCat Thrombectomy Catheter System. Catalog number 63000-01

FDA Recall Z-1115-2007 · Posted 2007-07-23

Recalling FirmKensey Nash Corp
Recall StatusTerminated
Product CodeMCW
Date Initiated2007-05-21
Date Terminated2007-08-29
Product Quantity11 units

Reason for Recall

Defective component (power supply)

Firm Action

New power supplies were sent directly to Sales Representatives who personally replaced the defective power supplies and returned them to Kensey Nash. A voice mail to all affected KNC Sales Representatives went out on 5/21/07 instructing them to contact the affected accounts immediately.

Root Cause

Other

Distribution Pattern

Nationwide:The products were shipped to medical facilities in FL, MO, NJ, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060016THROMCAT THROMBECTOMY CATHETER SYSTEMKensey Nash Corp. · 2006-04-25

Official Source

View FDA Recall →

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

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