Hays Ultrasound kit Item ID: H1000SE
Reported: June 30, 2021 Initiated: April 29, 2021 #Z-1918-2021
Product Description
Hays Ultrasound kit Item ID: H1000SE
Reason for Recall
No 510k for the product to be used in a natural or surgical opening to the body
Details
- Recalling Firm
- Exact Medical Manufacturing, Inc.
- Units Affected
- 10020 units
- Distribution
- US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
- Location
- Lancaster, NY
Frequently Asked Questions
What product was recalled? ▼
Hays Ultrasound kit Item ID: H1000SE. Recalled by Exact Medical Manufacturing, Inc.. Units affected: 10020 units.
Why was this product recalled? ▼
No 510k for the product to be used in a natural or surgical opening to the body
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 30, 2021. Severity: Moderate. Recall number: Z-1918-2021.
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