FDA recall, , Moderate risk
CareFusion 213 BD ChloraPrep and PurPrep Applicators
BD ChloraPrep and PurPrep applicators may be unsterile or contaminated with fungus, potentially causing serious infection or death.
Summary by Recall Canary from the FDA notice
What happened
CareFusion 213, LLC, of El Paso, Texas, recalled multiple BD ChloraPrep and BD PurPrep applicators because of lack of assurance of sterility. The products include ChloraPrep Frepp, ChloraPrep Hi-Lite Orange, ChloraPrep Clear, ChloraPrep Scrub Teal, and PurPrep. The recall began June 11, 2026, and was added to the FDA's Enforcement Report on June 29, 2026. The products were distributed nationwide in the USA.
What to do
If yours is listed below, or you can't tell:
- Customers and distributors should immediately discontinue use of and destroy all affected units in accordance with their facility’s process.
- Customer inquiries related to this recall, as well as adverse reaction/events experienced with the product, should be addressed to BD’s North American Regional Complaint Center: 1-844-823-5433 (Toll Free) Monday – Friday between the hours of 8a.m. and 5 p.m. CT or by emailing: productcomplaints@
bd.com.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Incomplete list: 114 of 174 lot codes shown.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co
- NDC
- 54365-400-30
- Lot code
- 3279063
- 3319524
- 3324094
- 3343541
- 3357638
- 4010202
- 4206771
- 4267824
- 4270191
- 4282285
- Exp.9
- 4338352
- 5053657
- 5121340
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA))
- NDC
- 54365-400-35
- Lot code
- 3362296
- 4066870
- 4104107
- 4276125
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co
- NDC
- 54365-400-34
- Lot code
- 4190081
BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, Sterile Solution, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co
- NDC
- 54365-400-31
- Lot code
- 4088933
- 4177711
- 4195438
- 5051114
- 5070540
- 5106254
- 5141607
- 5196494
Product details
BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co, Catalog Number 960120NSB
- NDC
- 54365-014-42
- Lot code
- 4298581
BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol)
- NDC
- 54365-400-39
- Lot code
- 3352149
- 5028798
- 5069651
- NDC
- 54365-400-36
- Lot code
- 4157798
- 5016842
- 5112542
- 3330777
- 3345111
- 4037991
- 4114505
- 4156664
- 4270441
- 5078395
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA)
- NDC
- 54365-400-32
- Lot code
- 3214024
- 3199359
- 3200136
- 3212372
- 3237018
- 3243267
- 3264290
- 3313291
- 3334121
- 4030693
- 4033380
- 4058103
- 4065931
- 4093245
- 4094302
- 4145548
- 4146564
- 4191049
- 4214794
- 4218807
- 4249036
- 4254217
- 4330005
- 4277387
- 4275877
- 4276225
- 4276231
- 4304554
- 4304577
- 4305852
- 4332555
- 4348701
- 4366429
- 5016607
- 5016609
- 5017377
- 5018775
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol)
- UPC
- 50872610
- Lot code
- 3194046
- 3217036
- 3279434
- 3286268
- 3304460
- 3346277
- 4031686
- 4039656
- 4048949
- 4060437
- 4067207
- 4092773
- 4094978
- 4106623
- 4120371
- 4129596
- 4144918
- 4193623
- 4200771
- 4227747
- 4250845
- 5093809
- 5121323
- 3331331
- 4284935
- 4344682
- 5015852
- 5086227
- NDC
- 54365-400-38
- Lot code
- 3291614
- 4034080
- 4036599
- 4081350
- 5008234
- 2320053
- 4151258
- 5084224
From the FDA notice
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.
Recall details
- Company began the recall
- Sold in
Distributed Nationwide in the USA
- Company
- CareFusion 213, LLCEl Paso, Texas
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99217
- Recall numbers
- D-0643-2026 to D-0652-2026
All recalls from CareFusion 213, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
