CareFusion 303, Inc. Recall 93106
Description: Alaris PCA Module 8120
CareFusion 303, Inc. Recall 93106 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0186-2024 |
| Event ID | 93106 |
| Event Description | Alaris PCA Module 8120 |
| Product Type | Devices |
| Distribution | 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 |
| Quantity | 86,393 units |
| Recall Reason | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. |
| Device Classification | 20231115 |
| Device Code Info | All Lots/ UDI-DI: 10885403516023,10885403515231,10885403801549,10885403515248, 10885403801532,10885403515224,10885403801518 |
| Center Classification Date | 20231106 |
| Recall Initiation Date | 20230915 |
| Recalling Firm | CareFusion 303, Inc. |
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