HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use w

FDA device recall Z-0825-2013 · posted 2013-02-15 · Terminated

Recall details

Recalling firm

Healthtronics, Inc.

Reason for recall

The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.

Action taken

Healthtronics sent an Urgent Device Recall letter dated December 20, 2012, to all affected customers that allows tracking. The letter included a suggested format/content for a correction status/acknowledgement letter. The customer was requested to complete the verification section of the recall letter and return all affected products to Healthtronics. A return material authorization (RMA) and pre-paid FedEx return labels was provided for all customers. All affected Healthtronics field personnell were notified of the recall via email. For questions regarding this recall call 512-439-8355.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

GEH

Quantity affected

50 units

Distribution

Nationwide Distribution including CA, CO, FL, GA, NC, NJ, OH, TX, and WI

Date initiated

2012-12-20

Date posted

2013-02-15

Date terminated

2013-04-22

Location

Austin, TX

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