CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Class I - DangerousWhat Should You Do?
- Check if you have this product: 14267-0901, 14452-0902, 15205-0904, 16147-0907, 16690-0909, 17431-0911, 17708-0912, 17913-1001, 18240-1002, 18308-1002, 18345-1002, 18511-1002, 18739-1003, 18829-1003
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Custom Medical Specialties, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in skin prep
Product Codes/Lot Numbers:
14267-0901, 14452-0902, 15205-0904, 16147-0907, 16690-0909, 17431-0911, 17708-0912, 17913-1001, 18240-1002, 18308-1002, 18345-1002, 18511-1002, 18739-1003, 18829-1003
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2355-2012
Related Recalls
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties, Inc.
Custom Medical Specialties
Sterility of syringe product could not be assured.
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
Custom Medical Specialties
No endotoxin (LAL) testing to proper level.
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
Custom Medical Specialties
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.