FDA Medical Device Recalls (openFDA)
Custom Medical Specialties, Inc.: CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
- Recall number
- Z-2352-2012
- Recalling firm
- Custom Medical Specialties, Inc.
- Product
- CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
- Status
- Terminated
- Initiated
- 2011-09-30
- Posted
- 2012-09-20
- Terminated
- 2013-04-29
- Reason
- 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.
- Root cause
- Material/Component Contamination
- Action
- Custom Medical Specialties sent an Urgent Medical Device Recall letter dated September 27, 2011 and a follow-up letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter requested that customers inspect inventory, discontinue use and return any remaining affected products. A Return Authorization Number and shipping number will be given to customer by calling 919-202-8462 ext 205. Customers were instructed to complete and return the attached Acknowledgement and Return Product form.
- Quantity
- 3 cases
- Distribution
- US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
- Lot, serial or model codes
- 14161-0901
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 3005474845
- Firm city
- Pine Level
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28