Hays Ultrasound kit recall
Hays Ultrasound kit Item ID: H1000SE
Why was Hays Ultrasound kit recalled?
No 510k for the product to be used in a natural or surgical opening to the body
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 2005E090 2006E495
- Product
- Hays Ultrasound kit Item ID: H1000SE
- Recalling firm
- Exact Medical Manufacturing, Inc.
- Quantity
- 10020 units
- Distribution
- US distribution to states of FL, MT, NY, OH, GA, and Puerto Rico
- Recall date
- June 30, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)