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North Coast Medical Inc Recall 88613

Description: EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208

North Coast Medical Inc Recall 88613 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2583-2021
Event ID88613
Event DescriptionEcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Aloe 5 liters, NC70482C/Eco Lotion with Aloe 5 liters (4); Myossage Lotion, 1 Gallon, Item: NC31208
Product TypeDevices
DistributionWorldwide distribution. US nationwide, Canada, Israel, South Africa, Australia, South Korea, France, Singapore, Grand Cayman, and Switzerland
Quantity53
Recall ReasonUltrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health
Device Classification20211006
Device Code InfoAll lots within the expiration date.
Center Classification Date20210929
Recall Initiation Date20210827
Recalling FirmNorth Coast Medical Inc
Initial Notification Letter
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