Z-1275-2012

CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature...

Name: Z-1275-2012 CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature...
Creator: Healthtronics, Inc.
Published: 2012-02-27
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2012-02-27 / Terminated / root cause: labeling and UDI

FDA source

Healthtronics, Inc. began a recall of CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature probes. Kit is intended to be used with the CryoCare... on 2012-02-27. The reason FDA records is "HealthTronics has initiated this recall of these products because there have been instances where the temperature probes (aka TempProbes) in the kit may be mislabeled. In some instances, the label near the prove does...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1275-2012
Status: Terminated
Initiated: 2012-02-27
Posted: 2012-03-21
Terminated: 2013-03-19
Recalling firm: Varian Medical Systems, Inc.
Product: CRYO-206V and CRYO-206F Procedure Kit, which includes: Cryo Probes, Urethral Catheter, and temperature probes. Kit is intended to be used with the CryoCare Surgical System for freezing/ablating tissue by extreme cold temperatures.
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: HealthTronics has initiated this recall of these products because there have been instances where the temperature probes (aka TempProbes) in the kit may be mislabeled. In some instances, the label near the prove does not match the label at the connector. If the labeling error went undetected, the TempProbes would not be monitoring temperature in the area believed to be under surveillance.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Endocare sent an Urgent: Device Recall letter dated February 27, 2012 to all affected consignees. The letter identified the affected product, problem and actions to be taken. The letter instructed consignees to immediately cease all distribution, examine their stock and the stock of accounts that have been supplied and remove any affected devices from all inventories. If the product have been further distributed contact Endocare for instruction. If consignees have any of the affected products: 1) Contact Customer Service at 877-367-4873 to obtain a RMA number, 2) Complete the Verification Section on page two, and 3) Return this letter with the affected product to the address provided. For questions about this recall contact Endocare, Inc at 877-367-4873.
Quantity in commerce: 9274 units
Distribution: Worldwide Distribution--USA (nationwide) and the countries of Barbados, Brazil, Canada, China, Italy, Jakarta, Malaysia, Madrid Spain, Taiwan, and United Kingdom.
Product codes and lots: Multiple codes.

Product code GEH

K101333Class IICryocare Cs Surgical SystemEndocare, Inc. / cleared 2010-06-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)