Probe Cover Elastic Poly 6" x 48"- Ultrasonic recall
Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
Why was Probe Cover Elastic Poly 6" x 48"- Ultrasonic 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: 1906E228 1907E501 1908E562 1910E027 1910E345 1911E263 1912E541 2003E241 2003E830 2010E342 2011E403
- Product
- Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
- Recalling firm
- Exact Medical Manufacturing, Inc.
- Quantity
- 129600 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)