Oartrac Prostate Immobilization Endorectal Balloon recall
OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are intended for…
Why was Oartrac Prostate Immobilization Endorectal Balloon recalled?
May result in readings outside of the expected accuracy range.
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: 114290, 114935 UDI 00851546007066
- Product
- OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Usage: pre-calibrated PSD sensors are intended for…
- Recalling firm
- Angiodynamics, Inc.
- Quantity
- 160 units
- Distribution
- US Nationwide distribution in the states of AZ, GA, MA, NJ, NY, OH, PA.
- Recall date
- December 25, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)