FDA recall Z-0736-2022

Product

CoolSeal Generator, REF: CSL-200-50

Reason for recall

A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of unintended energy to the patient.

Distribution

US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK

Key facts

Status

Terminated

Initiation date

2022-01-25

Report date

2022-03-16

Termination date

2024-05-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Louisville, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0736-2022