Product Safety Recalls

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Exact Medical Manufacturing, Inc. Recall 87958

Description: Hays Ultrasound kit Item ID: H1000SE

Exact Medical Manufacturing, Inc. Recall 87958 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1918-2021
Event ID87958
Event DescriptionHays Ultrasound kit Item ID: H1000SE
Product TypeDevices
DistributionUS distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
Quantity10020 units
Recall ReasonNo 510k for the product to be used in a natural or surgical opening to the body
Device Classification20210630
Device Code InfoLot Numbers: 2005E090 2006E495
Center Classification Date20210621
Recall Initiation Date20210429
Recalling FirmExact Medical Manufacturing, Inc.
Initial Notification E-Mail
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