CMS-4873 Custom CT Biopsy Tray recall: Contamination
CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in…
Why was CMS-4873 Custom CT Biopsy Tray 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?
16661-0909, 16662-0909, 17272-0910, 17566-0911, 17566-0911, 17923-1001, 18188-1001, 18195-1001, 18793-1003, 19158-1004
- Product
- CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in…
- Recalling firm
- Custom Medical Specialties, Inc.
- Quantity
- 538 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)