Why it was recalled
Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.
Product description
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15.
Lot numbers, UPCs & expiration codes
4452B
Where it was sold
Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1360-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 20, 2013
- FDA report date
- Jun 11, 2014
- Quantity
- 1,662,000 Surgical Scrub Brushes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Carefusion 2200 Inc
Original FDA data
Every field from FDA enforcement report D-1360-2014, exactly as published.
Show all FDA fields
- City
- Vernon Hills
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 68176
- Address
- 75 N Fairway Dr
- Code information
- 4452B
- Postal code
- 60061-1845
- Report date
- Jun 11, 2014
- Product type
- Drugs
- Recall number
- D-1360-2014
- Classification
- Class II
- Recalling firm
- Carefusion 2200 Inc
- Product quantity
- 1,662,000 Surgical Scrub Brushes
- Termination date
- Jun 11, 2015
- Reason for recall
- Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner. The available iodine in the product is less than as stated on the product label.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-013-15.
- Distribution pattern
- Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines
- Recall initiation date
- Dec 20, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 5, 2014