CLASS II Drug recall · Reported 11 Jun 2014 · FDA Enforcement Report
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail recalled
Carefusion 2200 is recalling CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine, distributed nationwide in the US. The recall was initiated on 20 Dec 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1359-2014
- FDA event ID
- 68176
- Recalling firm
- Carefusion 2200, Vernon Hills, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Dec 2013
- FDA classified
- 5 Jun 2014
- Reported
- 11 Jun 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 20 Dec 2013 | Recall initiated by company | |
| 5 Jun 2014 | Classified by FDA | +167 days |
| 11 Jun 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine (USP) Surgical Hand Scrub; CareFusion, Vernon Hills, IL 60061 USA, NDC 57613-003-18
Where it was distributed
Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines
Questions about this recall
Is CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine recalled?
Yes. Carefusion 2200 recalled CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povidone-iodine on 20 Dec 2013. The recall is Class II and its status is Terminated. Recall number D-1359-2014.
Why was it 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.
Which lots are affected?
4451B; 4451GL
Where was it sold?
Nationwide and Puerto Rico; Bahrain, Germany, Mexico, Philippines
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.