The Recall Desk
LowFDA (Devices)·Z-0825-2013·Announced 2013-02-27

HealthTronics RenalCryo Cryoprobe Recalled for Incorrect Expiration Label

Healthtronics, Inc. is recalling 50 units of Endocare 3.8mm RenalCryo Cryoprobes because the outer box labels display incorrect expiration dates.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a documentation and labeling issue (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.

Plain-English summary

Healthtronics, Inc. is recalling 50 units of the Endocare 3.8mm RenalCryo Cryoprobe, model R3.8L. The recall is due to incorrect expiration dates printed on the outer box labels. The affected products are identified by Lot 10180, with an expiration date on the box listed as 2105-07.

The Endocare CryoProbe is an accessory intended for use with the CryoCare Surgical System for freezing and ablation of tissue. The products were distributed nationwide, including in California, Colorado, Florida, Georgia, North Carolina, New Jersey, Ohio, Texas, and Wisconsin.

Healthcare providers and consumers should stop using the affected probes and contact Healthtronics, Inc. for further instructions or a replacement.

The recalled product

Product
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.
Affected units
50

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot 10180
  • Expiration date on box is 2105-07. Model Number R3.8L

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically: