BD Announces the Voluntary Recall of Specified Lots of ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator in the United States and U.S. Territories Due to Defective Applicator
Company Announcement
BD (Becton, Dickinson and Company), a leading global medical technology company, is voluntarily 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)) to the user level due to a defective applicator. 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. 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 only one laceration injury reported with respect to this issue.
As part of the voluntary recall to the user level, the company is notifying customers and distributors affected by the recall. BD’s Customer Recall Notification provides instructions to customers and distributors for disposal and replacement of the impacted ChloraPrep™ 26 mL Applicator (see list of affected lot numbers below).
To see the actual lots being recalled, please click below.
Comments