Recall: ChloraPrep Hi-Lite Orange 26 mL Applicator

IPSIS Patient Safety Alert 04/21/2021: ChloraPrep Hi-Lite Orange 26 mL Applicators Manufactured by BD 
(Becton, Dickinson and Company)

 Recalled Due to Defective Applicator

This is an important alert from the International Pain and Spine Intervention Society. IPSIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither IPSIS nor the FDA endorse either the product or the company.






ISSUE: BD (Becton, Dickinson and Company) is recalling specified lots of the ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) due to a defective applicator.

In
 certain lots, the applicator end cap was improperly secured due to a manufacturing error. This can result in broken glass and solution dropping out of the applicator once activated. In some cases, the glass ampules can drop out before activation and
 shatter if striking a hard surface, resulting in solution and glass fragments scattering in the procedure area and potentially causing injury to patients and health care professionals. These products were distributed in the United States and Puerto
 Rico.


BD RISK ASSESSMENT: Immediate health consequences could be lacerations to patient and/or user of the device. It is possible that these could range from superficial to deep lacerations. While BD has no current reports of severe injury,
 it is possible that lacerations could cause damage to structures such as nerves or tendons, however, this is considered unlikely. Long-term health consequences could include superficial or deep lacerations that could lead to infection and scarring.
 “Flying” glass shards could potentially cause injury to the patient or user, including eye injuries. Splashing ChloraPrep solution could contact the eyes of the user or patient. If tissues or organs other than the skin and subcutaneous tissues are
 damaged, permanent impairment could occur. While blood loss could accompany these injuries, it would be readily controllable with simple standard measures.

To date, BD has received 56 complaints with one laceration injury reported with
 respect to this issue. Click here for more
 information about this recall and the affected lot numbers.

BACKGROUND: The product is used as an antiseptic for the preparation of the patient's skin prior to surgery to help reduce bacteria that potentially can cause skin infection.
 The ChloraPrep 26 mL Applicator contains glass ampules that house the sterile ChloraPrep solution. In normal circumstances, the product is activated by squeezing the wing on the applicator to break the ampule, which releases the solution to the sponge
 head for application to the patient’s skin.

RECOMMENDATION: Customer inquiries related to this recall, as well as adverse reaction/events experienced with the product should be addressed to BD Customer Support at 1-844-8BD- LIFE
 (1-844-823-5433); When calling Monday- Friday between the hours of 9 a.m. to 6 p.m. ET, say “Recall” when prompted.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products
 to the FDA's
 MedWatch Adverse Event Reporting Program:



• Complete and submit the report online; or


• Download and complete the form, then submit it via fax at 1-800-FDA-0178





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