Z-0273-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 1, 2021
- Initiation Date
- September 27, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 devices
Product Description
Cardioblate CryoFlex Surgical Ablation Console
Reason for Recall
There is potential for intermittent electrical connectivity between the console and probe.
Distribution Pattern
Distribution in US - IL, KS, and UT Distribution outside of US to Australia and South Korea
Code Information
1) Model 65CS1: Serial 10047 (GTIN 00763000014988) Serial 10048 (GTIN 00763000014988) Serial 10050 (GTIN 00763000014988) Serial 1689 (GTIN 00643169183834) Serial CSC-591 (GTIN 00613994867315) Serial CSC055 (GTIN 00613994867315) Serial 10051 (GTIN 00763000014988) 2) Model R65CS1: Serial RCSC-201 (GTIN 00613994981516)