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Terminated

7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.

FDA Recall Z-1452-06 · Posted 2006-08-29

Recalling FirmCryoCath Technologies Inc.
Recall StatusTerminated
Product CodeLPB
Date Initiated2006-08-04
Date Terminated2007-01-16
Product Quantity34 units

Reason for Recall

Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1.

Firm Action

Consignees were notified by letter on 08/04/2006.

Root Cause

Other

Distribution Pattern

Nationwide, including AZ, CA, CO, CT, DE, FL, GA, KY, MD, MI, NE, NY, OH, PA, TX.

Official Source

View FDA Recall →

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

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