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

FDA device recall Z-1275-2012 · posted 2012-03-21 · Terminated

Recall details

Recalling firm

Healthtronics, Inc.

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.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

GEH

Quantity affected

9274 units

Distribution

Worldwide Distribution--USA (nationwide) and the countries of Barbados, Brazil, Canada, China, Italy, Jakarta, Malaysia, Madrid Spain, Taiwan, and United Kingdom.

Date initiated

2012-02-27

Date posted

2012-03-21

Date terminated

2013-03-19

Location

Austin, TX

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