6" x 96" Elastic Poly Probe Cover recall
6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
Why was 6" x 96" Elastic Poly Probe Cover 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: 1907E386 1911E049 1911E047 1911E261 1912E129 1912E128 2003E604 2003E633 2003E240 2003E932 2003E931 2005E439 2007E257 2010E215 2012E099 2012E506 2101E071
- Product
- 6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
- Recalling firm
- Exact Medical Manufacturing, Inc.
- Quantity
- 7920 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)