6" x 48" Elastic Poly Probe Cover recall
6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
Why was 6" x 48" 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: 1912E126 2002E133 2008E227 2008E226
- Product
- 6" x 48" Elastic Poly Probe Cover, T Tip,Tele Fold, 2 bands Item ID: A-AU-0852NA
- Recalling firm
- Exact Medical Manufacturing, Inc.
- Quantity
- 17545 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)