Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands recall
Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
Why was Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands 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: 1908E209 1908E435 2005E171 2007E030
- Product
- Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
- Recalling firm
- Exact Medical Manufacturing, Inc.
- Quantity
- 1600 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)