MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
Summary
The FDA issued a Class II for MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number by Cook Medical Llc. Reason: The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. Thi.
Details
Source
Device Recall
External ID
Z-0722-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
Product Description
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
Lot/Code Info: UDI-DI 00827002444294 Lots AM109365 AM109363 AM109356 AM111934 AM111932 AM111933 AM112041 AM112042 AM112039 AM112040 AM112043 AM112071 AM112072 AM112316
Quantity Affected: 14 US; 101 OUS
Reason for Recall
The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional medical procedure for the patient.
Distribution
Domestic distribution to CA IN LA MD NY International distribution to AUSTRALIA AUSTRIA SPAIN FINLAND FRANCE INDIA IRELAND ITALY KUWAIT SWITZERLAND TURKEY UNITED KINGDOM
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-07
Company
Bloomington, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cook Medical Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cook Medical Llc have FDA actions?
This is the only FDA action we have on record for Cook Medical Llc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0722-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29