Z-1378-2018 Class II Terminated
FDA device recall Z-1378-2018 was initiated by Cook Inc. on Jan 12, 2018 and is designated Class II. Reason for recall: The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater. The recall status is terminated (terminated May 8, 2020). Affected quantity: 4,451.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 25, 2018
- Initiation Date
- Jan 12, 2018
- Termination Date
- May 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,451
Product Description
MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
Reason for Recall
The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.
Distribution Pattern
Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)
Code Information
All Lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1378-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026