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 | |
| Similar To |