FDA Medical Device Recalls (openFDA)
CryoCath Technologies Inc.: 7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.
- Recall number
- Z-1452-06
- Recalling firm
- CryoCath Technologies Inc.
- Product
- 7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.
- Status
- Terminated
- Initiated
- 2006-08-04
- Posted
- 2006-08-29
- Terminated
- 2007-01-16
- Reason
- 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.
- Root cause
- Other
- Action
- Consignees were notified by letter on 08/04/2006.
- Quantity
- 34 units
- Distribution
- Nationwide, including AZ, CA, CO, CT, DE, FL, GA, KY, MD, MI, NE, NY, OH, PA, TX.
- Lot, serial or model codes
- Reference # 207F1, Lot number 00418.
- 510(k) numbers
- not on file
- PMA numbers
- ["P020045"]
- Product code
- LPB
- Firm FEI
- 3002648230
- Firm city
- Kirkland
- Firm state
- not on file
- Firm country
- Canada
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