FDAClass IMay 19, 2021

BD ChloraPrep Hi-Lite Orange recall

BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution, CareFusion…

Why was BD ChloraPrep Hi-Lite Orange recalled?

Defective Delivery System: An increase in complaints identified endcap being loose or falling off upon activation releasing glass shards containing the solution.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 0108186, Exp. 4/30/2023; 0327867, 0327868, 0328213, 0338656, 0339071, 0328947, 0328949, 0329475, 0329477, 0330457, 0330955, 0330606 0333826, 0333852, 0333855, 0334119, 0335787, 0335792, 0335029, 0336506 0336972, 0336051, 0337245, 0337025, 0338653, 0338542, 0338852, 0339892 0339457, Exp. 11/30/2023

Product
BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate (CHG) and 70% v/v Isopropyl alcohol (IPA)) Sterile Solution, CareFusion…
Recalling firm
CareFusion 213, LLC
Quantity
707,050 eaches
Distribution
Nationwide within the United States
Recall date
May 19, 2021
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls