ChloraPrep triple swabsticks recalled over lack of assurance of sterility
CareFusion 213 is recalling 106,400 units of BD ChloraPrep Triple Swabsticks over a lack of assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record states sterility cannot be assured for an antiseptic applied before procedures, and no injuries are reported.
Plain-English summary
BD ChloraPrep Triple Swabsticks, containing chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v in a 5.25 mL applicator, from CareFusion 213, LLC of El Paso, Texas, under NDC 54365-401-29, are being recalled.
The reason given in the enforcement record is a lack of assurance of sterility.
The recall covers 106,400 units from lot 5086623, expiry 03/31/2028. Distribution was nationwide within the United States. The FDA has classified the action as Class II.
A skin antiseptic without assured sterility may not be sterile when applied before a procedure. The enforcement record reports no injuries. Facilities should quarantine the affected lot and follow the firm's instructions.
The recalled product
- Product
- CHLORAPREP SWABSTICK (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP SWABSTICK
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Antiseptic
- Affected units
- 106,400
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 5086623
- Exp. Date 03/31/2028
Distribution
Distributed nationwide across the United States.
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