FDA Device recall Z-1513-2015
CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
- FDA Device
- Class II
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class II recall of CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01 by Csa Medical, citing truFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1513-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-25 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Csa Medical |
| Distribution | US |
Product
CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01
Reason
TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause: stricture,scarring, bradycardia, or pneumothorax
Identifiers
| code_info | Serial Numbers: 01-00106 through 01-00201 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1513-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.