Recently, the FDA of the United States has issued a number of recalls of medical devices, and the recall levels are all level I, Abbott, thalidomide, Medtronic, Ge, rishmail, etc. are listed on the list.
In terms of vehicle recall, BMW, Mercedes Benz and Kia have become the "three major recall households" in the near future, with the number of recalls more than one.
In terms of household products, domestic and foreign brands of electric hot water bottles and children's water bottles have issued recalls, and the hidden dangers of these daily products can not be underestimated.
This week, the fashion toy industry also received a recall news that attracted people's attention. Because of the plagiarism, the popular bubble Mart apologized and announced that its Ayla series blind boxes were removed from the shelves and recalled through all channels
Tytek medical - tm-317 air dart with partially or completely blocked needle - pneumothorax needle
Recalled product name and version: pneumodart, tm-317
Product Code: NSN 6515-01-655-9514 batch number: 190524j69
Manufacturing date: June 3, 2019 to September 17, 2019
Issue date: June 3, 2019 to September 17, 2019
Devices recalled in the United States: 920
Recall level: Level 1
Reason for recall:
Tytek medical is recalling its pneumodart pneumothorax needle due to the risk of needle blockage. The plugging of the needle is caused by the presence of adhesive during assembly. If the needle is blocked, emergency treatment may be delayed, which can lead to heart or lung failure or death. The affected equipment can cause additional injury because the diagnosis of lung injury can be complex. If the treatment with the first needle is unsuccessful, the caregiver may try to place another needle and may cause further lung collapse. At present, there is only one complaint with no casualties reported.
Follow up measures:
Tytek medical sent emergency medical device recall notifications to customers and distributors. Do not use any of the affected products. Tytek medical will recall the product from the distribution point and can be returned to: tytek medical immediately through UPS account r5513v or DHL account 958855282.
King systems - King vision visual laryngoscope adapter size 1 / 2
Recalled products:
King Vision video laryngoscope reusable adapter size ½, (kvlva12)
Batch No.: 010614, 010629, 010657, 010668, 010670, 010722
Serial number: lhxxxxxx10240, lhxxxxxx10243, lhxxxxxx10284, lhxxxxxx10554, lhxxxxxx10559, lhxxxxxx10562, lhxxxxxx10569, lhxxxxxx10570, lhxxxxxx10611, lhxxxxxx10666
Model: kvlva12
Manufacturing date: April 2, 2019 to September 19, 2019
Date of issue: AK, Al, CA, FL, IA, IL, KS, La, MD, Mn, MS, NC, NE, PA, SC, TX, WA and wi from August 2, 2019 to October 25, 2019
Devices recalled in the United States: 107
Recall level: Level 1
Reason for recall:
King systems is recalling the video adapter because all devices in the affected batch will display a reversed image on the display. Although the image may look normal, the user's operation will reverse to the left and right on the display. As defects are not easy to detect, the use of the affected video adapter may lead to serious adverse health events, including airway trauma and oxygen reduction in the body (hypoxia). The reversed image may also extend the time of tracheal tube placement, which may lead to brain damage, organ failure and death. No injuries or deaths have been reported.
Abbott: two kinds of arterial dilation catheter
Recall scope:
According to the FDA website, Abbott recalled the nctrek RX and NC traveler RX catheters. The models are: balloon diameter 4.0mm, 4.5mm and 5.0mm. The number of recalls is 13891, which is the first level recall - the most serious type of recall.
Reason for recall: Abbott is recalling relevant products because the saccules of the affected batch may not deflate as expected. This problem is due to over exposure to heat during manufacturing, resulting in weaker materials near the airbag joint. The use of these devices can lead to serious adverse health consequences, such as prolonged myocardial ischemia (less blowing of the heart), air embolism, thrombosis (clotting in the arteries), myocardial infarction (heart attack), and other postoperative complications that may lead to surgery, including death. So far, 13 complaints have been received related to this issue, with one reported death.
GE
1) Ge carestation 600 series anesthesia system
Recall scope:
Ge recalled Ge care 600 anesthesia system, model 620 / 650 / 650C, A1. Serial numbers: 1012-9620-000, 1012-9620-002, 1012-9650-000, 1012-9650-002, 1012-9655-000, 1012-9655-002. The number of recalls is 3599, which belongs to the first level recall.
Reason for recall:
GE Healthcare is recalling the carestation620 / 650 / 650C A1 anesthesia system because the cable connections inside the system may be loose, which may cause mechanical ventilation to stop working. If this happens, the system will issue a high priority audio-visual alert to alert healthcare providers. If the healthcare provider does not ventilate the patient manually or using other systems, the loss of mechanical ventilation may result in low blood oxygen levels (hypoxia). The use of the affected product may result in low blood oxygen levels in the patient, which may result in tissue or organ damage or death. No casualties.
2) Airway gas options n-caio, caresave breathing module
Recall scope:
According to FDA, Ge recalled n-caio (00840682104074) and caresave breathing module. The number of recalls is 165, which belongs to the first level recall.
The respiratory modules recalled above specifically include: e-sco (00840682104173); scovx (00840682104289; e-scaio (00840682104180); e-scaiov (00840682104142); e-scaioe (00840682104135302), e-sca.
Reason for recall:
Due to manufacturing issues, GE Healthcare is recalling the caresave respiratory module and airway gas options, which may cause the device to display incorrect oxygen values, which may result in high (low oxygen) or low (low oxygen) blood oxygen levels in patients. The use of the affected products may result in long-term high or low blood oxygen levels, which may lead to organ damage, tissue damage, increased risk of infection or death.
Medtronic - minimed600 series insulin pump
Recall scope:
According to the FDA website, Medtronic recalled the minimed600 series of insulin pumps, involving all batches of 630g type (mmt-1715) - before October 2019, and all auctions of 670g type (mmt-1780) - before August 2019. The number of recalled products is 322005, which belongs to the first level recall.
Reason for recall:
Medtronic is recalling a designated insulin pump due to a missing or damaged retaining ring, which helps to lock the insulin cartridge into the pump's reservoir. If the cartridge is not firmly locked in place, insufficient or excessive insulin delivery can occur, which can lead to hypoglycemia or hyperglycemia. Severe hyperglycemia can lead to loss of consciousness, seizures and death. The company received a total of 26421 complaints of equipment failure in this way. The company is aware of 2175 injuries and one death.
Rismai stellar ventilator
Recall scope:
The products recalled by rismai are stellar respirators, with models of 100 and 150, totaling 69, which belong to the first level recall.
Noninvasive and invasive ventilator models: 100 and 150, serial number range: 20160123307 to 22171057208
Production date: April 2016 to June 2017
Issue date: April 2016 to November 2017
Devices recalled in the United States: 69
Recall level: Level 1
Reason for recall:
Under certain circumstances, no audible alarm will be given. Leading to serious consequences, including the risk of serious injury or death.
teleflex
1) Comfort flo humidification system, ref 2410, humidifier atomizer Kit
Recall scope:
According to the FDA website, taliford recalled different versions of products such as comfortflo humidification system, ref 2410, humidifier atomizer kit, etc. The number of recalls is 398320, which belongs to the first level recall.
Reason for recall:
Teleflex medical is recalling its comfort flo humidification system because water can flood the column and enter the system loop. If water enters the circuit, it may enter the patient's nose and lungs. The use of the affected products can have serious adverse health consequences, including low oxygen (desaturation) in the blood and the need for further treatment to prevent long-term or serious injury. The device has received 102 complaints and 8 injuries, including low oxygen (desaturation) in the blood and slower than normal heart rate (bradycardia). No deaths were reported.
2) Continuous positive pressure oxygen nasal catheter for babi plus infants
Recalled product: galemedbabi. Plus ® 12.5cm H2O relief port
Product Code: 2691
Code: 180806, 180910, 181029, 181105, 181204, 190225, 190327
Issue date: October 2018 to may 2019
Equipment recalled in the United States: 14964
Recall level: Level 1
Reason for recall:
Teleflex is recalling the babi.plus pressure relief manifold system because the pressure relief manifold (PRM) in the babi.plus 12.5 cm H2O pressure relief manifold originally installed on the patient does not maintain pressure. This problem is caused by a displaced valve that is not properly seated, resulting in a loss of pressure in the system. The use of the affected equipment can lead to serious adverse health consequences, including lowering the oxygen level in the blood, lowering the heart rate, stopping breathing (apnea), the patient's exhaled carbon dioxide, and methods requiring medical intervention and resuscitation. The reason is that the system received two complaints related to equipment failure.
Follow up measures:
Thalido requires that the product be immediately discontinued and quarantined, that the attached recall confirmation be completed as soon as possible, that it is in stock, and that it be faxed to 1-855-419-8507, or to callbacks@teleflex.com or to a sales representative.
BMW (China) Automobile Trade Co., Ltd. recalled some imported c400gt, c400x, g310gs and g310r motorcycles
Recall scope:
Recently, BMW (China) Automobile Trade Co., Ltd. filed a recall plan with the State Administration of market supervision and administration in accordance with the requirements of the regulations on the administration of recall of defective automobile products and the measures for the implementation of the regulations on the administration of recall of defective automobile products. Since February 29, 2020, 7157 imported c400gt, c400x, g310gs and g310r motorcycles produced between April 23, 2016 and November 30, 2019 have been recalled.
Reason for recall:
For some vehicles within the scope of this recall, when the deicing agent containing calcium chloride is used on the road, the deicing agent may be involved in the inner surface of the brake caliper with the accumulation of water on the road, and corrosion may occur on the inner surface of the brake caliper due to the lack of anti-corrosion protection with the increase of vehicle mileage. If the corrosion occurs at the sealing ring of the caliper piston, the corrosion may activate the piston return Dynamic degrees of freedom produce resistance. If the above abnormalities are not detected and repaired in time, in extreme cases, the driver's brake operation may be released, but the brake caliper still remains clamped in the braking state, and the additional braking force may affect the driver's control of the vehicle balance, resulting in a car crash or rear end collision, which may cause safety hazards.
Follow up measures:
BMW (China) Automobile Trade Co., Ltd. will carry out inspection for the recalled vehicles and replace the improved brake calipers free of charge to eliminate the safety risks. It is expected that the first batch of improved parts for recall maintenance will arrive at home in the middle of the first quarter of 2020, and the supply of improved parts will be sufficient in the second quarter of 2020