FDAFDA · Food and drugs·Recall number Z-0825-2013
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.
Published February 27, 2013 · Recall initiated: December 20, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Healthtronics, Inc.
- Distributor
- Nationwide Distribution including CA, CO, FL, GA, NC, NJ, OH, TX, and WI
- Lot
- Lot 10180, Expiration date on box is 2105-07. Model Number R3.8L
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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