Class 2 Device Recall KMINC1000 Mini Incubator

• Date Initiated by Firm: December 16, 2020
• Create Date: January 08, 2021
• Recall Status: Terminated on November 08, 2023
• Recall Number: Z-0809-2021
• Recall Event ID: 86965
• 510(K)Number: K983642
• Product Classification: Accessory, assisted reproduction - Product Code MQG
• Product: Disposable Humidification Flask, Reference Part Number K-MINC-CTS-S, Order Number G32707
• Code Information: Lot Numbers: A1007159 A1007162 A1007163 A1007164 A1007160 A1007161 A1007406 A1007409 A1007405 A1007407 A1007408 A1007410 A1007662 A1007663 A1007661 A1007660 A1007838 A1007837 AC1007995 A1008104 A1008105 A1008110 A1008252 A1008253 A1008255 A1008254 A1008484 A1008485 A1008483 A1008491 A1008675 A1008677 A1008673 A1008674 A1008676 A1008709 A1008710 A1008714 A1008715 A1008942 A1008943 A1008946 A1008945 A1008944 A1008947 A1009066 A1009067 A1009271 A1009274 A1009275 A1009272 A1009273 A1009477 A1009478 A1009479 A1009548 A1009549 AC1009536 A1009480 A1009674 A1009675 A1010176 A1010177 A1010232 A1010234 A1010237 A1010235 A1010233 A1010236 A1010596 A1010597 A1010594 A1010595 A1010598 A1011063 A1011062 A1011058 A1011059 A1011060 A1011061 A1011294 A1011295 A1011297 A1011293 A1011296 A1011298 AC1011434 A1011533 A1011528 A1011529 A1011531 A1011532 A1011530 A1011785 A1011790 A1011787 A1011788 A1011789 A1011786 A1009065 A1012899 A1012901 A1012903 A1012902 A1012900 A1012904 A1013105 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• Recalling Firm/ Manufacturer: Cook Medical Llc; 1025 W Acuff Rd; Bloomington IN 47404-9295
• Manufacturer Reason for Recall: A small percentage of the Disposable Humidification Flasks may have a manufacturing defect that can cause the silicone stoppers to dislodge or gas to leak from the flasks, impeding gas flow to the incubation chambers of the Mini Incubator.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 12/16/20 was sent to customers. Action to be Taken: As a precautionary measure, we recommend that users perform two in-house checks prior to using a new flask to improve detection of the manufacturing defect. 1. Visual Inspection Check the flask assembly: when the stopper is placed on the flask, the tab on the silicone stopper should engage with the indent in the flask. Flasks that have the defect may not allow the stopper to be fully pushed into the indent of flasks, as shown in Figure 1. 2. Leak Test Check for leaks: Flasks that have the defect will cause a gas leak that will impede gas flow into the Mini Incubator. a. Prepare the Mini Incubator by removing any flasks. b. Fill the flask to be tested with sterile distilled water (to the fill line) and insert it into the incubator. c. Set the flow rate to 15mL/min and wait for the purge cycle to complete. d. Block the gas flow from both tubes exiting the flask by kinking and holding the tubes as shown in Figure 2. i. When the tubes are folded, the area around the folds may appear white  this does not indicate that the silicone tubing has been damaged. e. If the gas flow does not fall to zero within 45 seconds, the flask may be defective. f. Unblock the tubes as soon as the flow reaches zero; blocking the tubes for more than two minutes may cause pressure to build up in the flask and the silicone stopper to suddenly pop off. i. Gas flow may be greater than 15mL/min immediately after the tubes are unblocked. This is normal  the incubator will gradually adjust the gas flow rate to the correct value. g. If a potential defect is discovered, please take a photo and report this to Cook Medical Customer Relations, customerrelationsNA@cookmedical.com or 1-800-4574500, extension 152146, referencing FAIP 2020-0006 , in order to obtain a credit for the faulty product. Do not use the flask if a potential defect is discovered. Dispose of
• Quantity in Commerce: 56250
• Distribution: US Nationwide
• 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