CareFusion

BD ChloraPrep Clear, a sterile skin antiseptic solution used before medical procedures, may have open or incomplete seals on individual applicator packaging. This could allow contamination of the sterile product. The issue affects multiple lot numbers distributed nationwide.

BD ChloraPrep CLear applicators intended for further processing and sterilization were distributed directly to customers without being sterilized first. The product is a skin antiseptic used before medical procedures. No injuries have been reported.

BD ChloraPrep CLear, a chlorhexidine-based skin antiseptic solution in single-use applicators, was distributed without proper sterilization. Unsterilized applicators intended for further processing were mistakenly sent to customers outside the intended distribution channel. This affects 18,000 units across multiple lot numbers distributed nationwide.

BD ChloraPrep Scrub Teal applicators intended for further processing and sterilization were mistakenly distributed as finished sterile products. The affected applicators may not meet sterility standards required for safe use in medical settings.

BD ChloraPrep Scrub Teal applicators intended for further processing and sterilization were distributed to customers without having been sterilized. The unsterilized applicators reached customers outside the intended distribution channel. About 1,200 units are affected.

BD ChloraPrep Hi-Lite Orange skin antiseptic applicators were distributed without proper sterilization. These units were intended for further processing and sterilization before use, but were instead sent directly to customers. This creates a risk of infection if the applicators are used as distributed.

BD ChloraPrep Hi-Lite Orange applicators intended for further sterilization before use were mistakenly distributed directly to customers without undergoing the required sterilization process. These applicators are used to prepare skin before medical procedures and must be sterile to be safe. The recall affects specific lot numbers distributed nationwide.

CareFusion distributed unsterilized ChloraPrep FREPP applicators (chlorhexidine gluconate and isopropyl alcohol solution) to customers outside their intended distribution channel. These applicators were meant for further processing and sterilization before use, but were shipped to end users without that sterilization step, creating a risk of infection if used on patients.

BD ChloraPrep Clear applicators (a skin-prep solution containing chlorhexidine and isopropyl alcohol) were distributed without proper sterilization. These applicators were intended to be sterilized before sale but were sent to customers in an unsterilized state. The affected products are in 3 ml applicator packs, with multiple lot numbers expiring between June 2026 and February 2029.

BD PurPrep sterile applicators (povidone-iodine with isopropyl alcohol) were distributed without proper sterilization assurance. Unsterilized applicators intended for further processing were shipped to customers outside the intended distribution channel, affecting Lot 4298581 (expires 09/30/2026).

BD ChloraPrep Hi-Lite Orange applicators (a skin antiseptic used before medical procedures) were distributed without proper sterilization. These applicators were intended to be sterilized before use, but some unsterilized units were sent to customers outside the normal supply chain.

BD ChloraPrep FREPP Clear, a sterile skin antiseptic applicator, may contain fungal contamination (Aspergillus penicillioides) or may not be fully sterile due to wrinkles in the packaging seal. Approximately 178,000 applicators from lot 4073005 (expiring 03/31/2027) are affected nationwide and internationally.

BD ChloraPrep Clear, a sterile antiseptic skin-prep solution used before medical procedures, was found to contain Aspergillus penicillioides fungus in some applicators. This affects the sterility of the product, which is critical for medical use. The affected lot is Lot #4032183 with an expiration date of January 31, 2027.

BD ChloraPrep FREPP Clear applicators may have wrinkles in the paper lid that could compromise the sterile seal. This affects multiple lot numbers distributed nationwide through mid-2027. No injuries have been reported.

BD ChloraPrep Clear, a sterile skin antiseptic solution used before medical procedures, is being recalled because wrinkles in the paper packaging lid may allow the sterile seal to be breached. This defect could potentially allow contamination of the product. No injuries have been reported.

The labeling on BD Alaris System with Guardrails Suite MX does not specify which version of Transport Layer Security (TLS) must be enabled on hospital networks for secure Wi-Fi communication with Point-of-Care Units. This could create confusion during setup and potentially leave devices with inadequate security settings.

Some BD Alaris Pump Module 8100 infusion pumps have a software date/time issue related to daylight saving time that may prevent them from connecting to hospital networks. This affects only the network connectivity function; the pump's ability to deliver medication is not impacted. The issue involves 189 devices distributed in Arizona, Indiana, Ohio, and Virginia.

A software issue in certain BD Pyxis ES Enterprise Server systems may prevent timely updates of patient, medication, and related information from reaching the dispensing cabinets. This could delay access to critical data in healthcare settings. BD and the FDA are working to address the problem.

CareFusion 213, LLC is recalling BD ChloraPrep Triple Swabsticks (a skin antiseptic swab) because the manufacturer cannot confirm the product was properly sterilized. The affected lot (#5086623, expiring 3/31/2028) was distributed nationwide. No injuries have been reported.

BD Pyxis automated medication dispensing cabinets used in hospitals and pharmacies received a firmware update that caused certain drawers to fail. When a drawer fails, staff may have difficulty accessing or restocking medications, which could delay patient care.

If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.