| Date Initiated by Firm | January 12, 2018 |
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| Date Posted | April 13, 2018 |
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| Recall Status1 |
Terminated 3 on May 08, 2020 |
| Recall Number | Z-1377-2018 |
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| Recall Event ID |
79711 |
| 510(K)Number | K983642 |
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| Product Classification |
Accessory, assisted reproduction - Product Code MQG
|
| Product | MINC Benchtop Incubator (Mini Incubator)
catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture. |
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| Code Information |
All lots |
Recalling Firm/
Manufacturer |
Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
|
| For Additional Information Contact | Cook Medical
812-339-2235 Ext. 10214 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Device Design |
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| Action | 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 |
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| Quantity in Commerce | 483 |
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| Distribution | Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide) |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = MQG
|
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