Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.
Reason for recall: Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. 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 Quantity: 86,393 units Lot/code info: All Lots/ UDI-DI: 10885403516023,10885403515231,10885403801549,10885403515248, 10885403801532,10885403515224,10885403801518
10885403516023, 10885403515231, 10885403801549, 10885403515248, 10885403801532, 10885403515224, 10885403801518
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.