CLASS II Drug recall · Reported 26 Sep 2012 · FDA Enforcement Report
ChloraPrep with Tint, HI-Lite Orange Applicator recalled
Carefusion 213 is recalling ChloraPrep with Tint, HI-Lite Orange Applicator, Patient Preoperative Skin Preparation, distributed nationwide in the US. The recall was initiated on 8 Nov 2011 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-1674-2012
- FDA event ID
- 62971
- Recalling firm
- Carefusion 213, El Paso, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Nov 2011
- FDA classified
- 17 Sep 2012
- Reported
- 26 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
Timeline
| 8 Nov 2011 | Recall initiated by company | |
| 17 Sep 2012 | Classified by FDA | +314 days |
| 26 Sep 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
Where it was distributed
Nationwide
Questions about this recall
Is ChloraPrep with Tint, HI-Lite Orange Applicator, Patient Preoperative Skin Preparation recalled?
Yes. Carefusion 213 recalled ChloraPrep with Tint, HI-Lite Orange Applicator, Patient Preoperative Skin Preparation on 8 Nov 2011. The recall is Class II and its status is Terminated. Recall number D-1674-2012.
Why was it recalled?
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Which lots are affected?
Product code 260415, Lot#: 48225
Where was it sold?
Nationwide
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.
More recalls from Carefusion 213
All 48| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate recalledChloraprep One-step | CareFusion 213 | Sterility | Nationwide |
| Drug | CLASS II | BD ChloraPrep Hi-Lite Orange recalled by CareFusion 213Chloraprep One-step | CareFusion 213 | Sterility | Nationwide |