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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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.
- Manufacturer
- Healthtronics, Inc.
- Hazard
- 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
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