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Recall Observatory FDA recall evidence

Device product

BD Alaris Syringe Module, REF 8110

Z-0185-2024

September 15, 2023

Class I

Product summary

Firm
CareFusion 303, Inc.
Event
Event 93106
Status
Ongoing
Classification
Class I
Quantity
133,727 units
Official record key
device-enforcement:Z-0185-2024

Official wording

Reason: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

Code information: All Lots/ UDI-DI:10885403516047, 10885403515323, 10885403811043, 10885403515255 10885403811036, 10885403515262, 10885403811012, 10885403515279, 10885403424267

Distribution pattern: Worldwide Distribution: US (nationwide): AK, AL, AR, AS, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; OUS (foreign): Canada, Germany, Cuba, Italy, Japan, South Korea, Turkey, United Arab Emirates, Australia, Bahrain, Botswana, Kuwait, Mexico, Netherlands, Philippines, Pakistan, Qatar, South Africa, Singapore, Belgium, Israel, India, New Zealand, Malaysia, Taiwan, Switzerland

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.