HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue.
FDA Recall Z-0825-2013 · Posted 2013-02-15
Advertisement
Recalling FirmHealthtronics, Inc.
Recall StatusTerminated
Product CodeGEH
Date Initiated2012-12-20
Date Terminated2013-04-22
Product Quantity50 units
Reason for Recall
The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.
Firm Action
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
Distribution Pattern
Nationwide Distribution including CA, CO, FL, GA, NC, NJ, OH, TX, and WI
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement