MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidif
FDA device recall Z-1377-2018 · posted 2018-04-13 · Terminated
Recall details
- Recalling firm
- Cook Inc.
- 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.
- Action taken
- Cook plans to begin notifying consignees of the recall on January 12, 2018 Written recall communication letters will be mailed via courier to US consignees
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MQG
- Quantity affected
- 483
- Distribution
- Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)
- Date initiated
- 2018-01-12
- Date posted
- 2018-04-13
- Date terminated
- 2020-05-08
- Location
- Bloomington, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COOK MINI-INCUBATOR (K983642) | Cook Ob/Gyn | 1999-02-01 |