BD Response

Last Update: June 15 2021, 9:40 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. This new packaging launched in May 2021 and is now available to US customers. The BD ChloraPrep™ 10.5 mL and 26 mL products currently use the same Tyvek packaging material that you will now find on your new BD ChloraPrep™ 3 mL product.

To Check 3mL Product Lots with the New Tyvek Packaging, Here Are Two Options:

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 caused by two external issues: (1) a third-party manufacturing constraint for the BD ChloraPrep™ 1 mL applicator body, which caused a reduction of manufacturing output; and (2) a supply shortage from one of our third-party suppliers of the resin used to create the BD ChloraPrep™ 1 mL single sterile packaging.

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

June 2021 substitution plan
July and beyond substitution plan

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.

BD has prioritized the production and supply of the BD ChloraPrep™ 1 mL non-sterile bulk code to limit supply disruption for our kitting partners who service our customers. If you currently purchase kits containing BD ChloraPrep™ 1 mL from third party suppliers, you should only expect minimal impact to the BD ChloraPrep™ 1 mL NSB supply. 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 NSB beyond your typical order volume.