CSA Medical truFreeze Console Cryosurgical Unit Recalled for Excess Liquid Nitrogen Delivery
CSA Medical is recalling 82 truFreeze Console cryosurgical units because they may deliver excessive liquid nitrogen, posing risks of stricture, scarring, bradycardia, or pneumothorax.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a device malfunction that may cause significant injuries such as pneumothorax and bradycardia, meeting the criteria for a Severe rating.
Plain-English summary
CSA Medical is recalling 82 units of the truFreeze Console Cryosurgical Unit, Model CC3-01. The recall affects serial numbers 01-00106 through 01-00201. These devices were distributed nationwide.
The recall was initiated because the TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered. This malfunction may cause stricture, scarring, bradycardia, or pneumothorax in patients.
The U.S. Food and Drug Administration classifies this as a Class II recall. Consumers and healthcare providers should stop using the affected devices and contact CSA Medical for instructions on replacement or repair.
The recalled product
- Product
- CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
- Manufacturer
- CSA Medical
- Affected units
- 82
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 (1)
- Serial Numbers: 01-00106 through 01-00201
Distribution
Distributed nationwide across the United States.
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