Recall record at a glance
| Official record | Z-1377-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Cook Inc. |
| Report date | Apr 25, 2018 |
| Recall initiation date | Jan 12, 2018 |
| Quantity | 483 |
| Location | Bloomington, IN, United States |
Official product description
MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
Why the product was recalled
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 information
Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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