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Recall Observatory FDA recall evidence

Drug product

BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, bulk catalog number 930725NSB; STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co.

D-0649-2026

June 11, 2026

Class II

Product summary

Firm
CareFusion 213, LLC
Event
Event 99217
Status
Ongoing
Classification
Class II
Quantity
1,200 units
Official record key
drug-enforcement:D-0649-2026

Official wording

Reason: Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

Code information: Lot: a) 4157798, Exp 05/31/2027, 5016842, Exp 12/31/2027, 5112542, Exp 04/30/2028 b) 3330777, Exp 10/31/2026, 3345111, Exp 12/31/2026, 4037991, Exp 01/31/2027, 4114505, Exp 04/30/2027, 4156664, Exp 05/31/2027, 4270441, Exp 09/30/2027, 5078395, Exp 03/31/2028

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of assurance of sterility

Field note

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