BD Response

Last Update: November 3, 2021
9:30 am EDT

BD is committed to patient safety and customer satisfaction, and we are taking every step we can to address this situation as quickly as possible. Our goal is to meet the needs of all our customers to the best of our ability and limit the time to restock.

BD is working diligently to mitigate the impact of these factors on BD ChloraPrep™ supply:

Below is more detailed information about each affected product with links to the BD website.

Product Situation/BD Response

Situation: On April 20, 2021, BD conducted a voluntary recall on certain lots of the BD ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator (930815) in the United States and U.S. Territories. For more details on the recall and affected lot numbers, please view this customer letter.

BD Response: After a thorough investigation BD has identified the root cause of the issue and has implemented corrective actions at the manufacturing facility. BD is replacing all discarded inventory for the BD ChloraPrep™ 26 mL recall with unaffected BD ChloraPrep™ Hi-Lite Orange™ 26 mL Applicators.
Situation: On June 23, 2020, BD conducted a voluntary recall on the BD ChloraPrep™ 3 mL product for those regions of the world where the product was exposed to 30°C / 75%RH. On March 19, 2021, BD expanded the scope of the BD ChloraPrep™ 3 mL recall with catalog numbers listed in this customer letter (260400, 260415, 930400, 930415) to include all 50 U.S. states. There has been no identified risk associated with the sterile ChloraPrep™ antiseptic solution within the applicator.

BD Response: BD has changed the top lidding of all BD ChloraPrep™ 3 mL product unit level packaging in the US from medical grade paper to Tyvek 2FS. All US products shipped since May 2021 are made with Tyvek 2FS. To confirm the packaging of any specific lot, check BD’s official recall page.

Please note SKUs ending with NS were not subject to the 3mL recall. BD is updating the packaging of these SKUs from paper to Tyvek packaging to ensure consistency across the portfolio. This will be a rolling change.

BD ChloraPrep™ 1 mL Supply Interruption:

Situation: BD is currently experiencing a supply interruption for the BD ChloraPrep™ 1 mL single sterile applicator (930480), which will become temporarily unavailable starting May 2021 through Fall 2021. This interruption is currently caused by a third-party manufacturing constraint for the BD ChloraPrep™ 1 mL applicator body, which caused a reduction of manufacturing output.

BD Response: BD has identified various potential short-term options to help mitigate these issues:

September thru October
November and beyond substitution plan

* The BD ChloraPrep™ swabstick applicators contain nonsterile solution.

For allocation planning, BD will be using a conversion calculator of 2 cases of BD ChloraPrep™ 1 mL to 1 case of BD ChloraPrep™ Swabstick or 1 case of BD ChloraPrep™ FREPP™ 1.5 mL.

If you currently purchase kits containing BD ChloraPrep™ 1 mL from third party suppliers, you should only expect minimal impact. It is important to note that your kitting partners may not be able to take on incremental demand of kits containing BD ChloraPrep™ 1 mL beyond your typical order volume.