Exact Medical Manufacturing, Inc. Recall 87958
Description: Hays Ultrasound kit Item ID: H1000SE
Exact Medical Manufacturing, Inc. Recall 87958 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1918-2021 |
Event ID | 87958 |
Event Description | Hays Ultrasound kit Item ID: H1000SE |
Product Type | Devices |
Distribution | US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico |
Quantity | 10020 units |
Recall Reason | No 510k for the product to be used in a natural or surgical opening to the body |
Device Classification | 20210630 |
Device Code Info | Lot Numbers: 2005E090 2006E495 |
Center Classification Date | 20210621 |
Recall Initiation Date | 20210429 |
Recalling Firm | Exact Medical Manufacturing, Inc. |
Initial Notification | |
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