BD (Becton, Dickinson and Company), a worldwide medical technology leader, is voluntarily recalling certain lots of the ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator (2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) to the user level because the applicator is defective. The product is for use as an antiseptic to prepare the patient’s skin pre-operatively to decrease bacteria that have the potential to cause infection of the skin.
The ChloraPrep™ 26 mL Applicator includes glass ampules that contain the sterile ChloraPrep™ solution. Under normal conditions, the product is activated by squeezing the wing on the applicator to rupture the ampule, releasing the solution to the sponge head to apply to the patient’s skin. In some lots, the end cap on the applicator was not properly secured because of a manufacturing defect. This can lead to shattered glass and solution falling out of the applicator upon activation. Occasionally, the glass ampules fall out prior to activation and break if they hit a hard surface, leading to solution and glass particles spreading on the procedure area and having the capability of causing harm to patients and health care workers. The products were released in the United States and Puerto Rico.
BD Risk Assessment
The immediate health effects may be laceration to patient and/or user of the device. These may be from superficial to deep lacerations. BD does not have any current reports of serious injury, but lacerations may lead to damage of structures like nerves or tendons, though this is deemed improbable. Long-term health effects may be superficial or deep cuts that may result in infection and scarring. “Flying” glass pieces may cause harm to the patient or user, such as eye damage. Splashing ChloraPrep™ solution may reach the user’s or patient’s eyes. If tissues or organs other than skin and subcutaneous tissues are injured, permanent damage may result. Although blood loss may be secondary to these types of injuries, it would easily be manageable using basic standard control measures. BD has so far received 56 complaints with a single laceration injury noted in relation to this problem.
As a voluntary recall to the user level, the company is informing the customers and distributors involved in the recall. BD’s Customer Recall Notification gives customers and distributors directions to dispose of and replace the affected ChloraPrep™ 26 mL Applicator (see below for list of affected lot numbers).
| Catalog No. | Product | Lot Number | Expiration Date |
| 930815 | BD ChloraPrep™ Hi-Lite Orange™ 26mL Applicator | 0108186 | 04/30/2023 |
| 0327867 0327868 0328213 0328947 0328949 0329475 0329477 0330457 0330606 0330955 0333826 0333852 0333855 0334119 0335029 0335787 0335792 0336051 0336506 0336972 0337025 0337245 0338542 0338653 0338656 0338852 0339071 0339457 0339892 | 11/30/2023 |
Questions from customers regarding this recall, and adverse reaction/events associated with the product should be directed to BD Customer Support at 1-844-8BD- LIFE (1-844-823-5433); When calling Monday- Friday between 9 a.m. to 6 p.m. ET, say “Recall” when asked. For more information, customers can call www.bd-chloraprep-action.comExternal Link Disclaimer. Consumers should ask their physician or healthcare professional if they have had any issues that could be connected to taking this drug product.
The U.S. Food and Drug Administration has been informed about this recall.
FDA MedWatch Reporting
Unfavorable reactions or quality issues encountered with the use of this product can be reported to the FDA’s MedWatch Adverse Event Reporting program either on-line by regular mail or fax.
- Online Complete and submit the report
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to ask for a reporting form, then print and mail to the address listed on the pre-addressed form, or fax to 1-800-FDA-0178
