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CareFusion 303, Inc. Recall 93106

Description: Alaris PCA Module 8120

CareFusion 303, Inc. Recall 93106 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0186-2024
Event ID93106
Event DescriptionAlaris PCA Module 8120
Product TypeDevices
DistributionWorldwide 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
Quantity86,393 units
Recall ReasonAlaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
Device Classification20231115
Device Code InfoAll Lots/ UDI-DI: 10885403516023,10885403515231,10885403801549,10885403515248, 10885403801532,10885403515224,10885403801518
Center Classification Date20231106
Recall Initiation Date20230915
Recalling FirmCareFusion 303, Inc.
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