REGARD Core Biopsy Tray recall
REGARD Core Biopsy Tray
Why was REGARD Core Biopsy Tray recalled?
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
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?
Lots numbers: 88004C, 87367C, 86986C, 83380C, 83062C, 82614C, 86178C and 85427C
- Product
- REGARD Core Biopsy Tray
- Recalling firm
- ROi CPS LLC
- Quantity
- 1,200 trays
- Distribution
- US Nationwide in the states of FL, LA and MO.
- Recall date
- November 24, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)