CMS-8495-R5 Custom Vein Tray containing recall: Contamination
CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Why was CMS-8495-R5 Custom Vein Tray containing recalled?
The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper finished goods specifications.
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?
15924-0906, 16975-0910, 17709-0912
- Product
- CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
- Recalling firm
- Custom Medical Specialties, Inc.
- Quantity
- 15 cases
- Distribution
- US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
- Recall date
- September 26, 2012
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)