EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the destination container in compounding of large-v
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is recalling EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN bags in four sizes (250mL, 500mL, 1000mL, and 200mL) due to a potential ability to leak once used for compounding. Approximately 11.3 million units have been distributed worldwide, including throughout all U.S. states and multiple countries including Canada, Australia, New Zealand, Singapore, Korea, Thailand, Brazil, Mexico, and Chile. The affected products are identified by specific product codes (H938737, H938738, H938739, H938740) and numerous lot numbers beginning with 600.
The record does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential ability to leak once used for compounding.
Reason for recall: Potential ability to leak once used for compounding. Distribution: Worldwide distribution - UD Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. The countries of Canada, Australia, New Zealand, Singapore, Korea, Taiwan, Thailand, Hong Kong, Brazil, Columbia, Mexico, Chile, Urug Quantity: 11,389,800 units total Lot/code info: 1. UDI Number: 00085412477213, Lot Numbers (60060391, 60061809, 60061816, 60061819, 60063137, 60063138, 60063141, 60063142, 60063143, 60063146, 60063147, 60063148, 60064545, 60064546, 60064547, 60064548, 60064549, 60064551, 60064552, 60064553, 60064554, 60066253, 60066254, 60066255, 60066256, 60066257, 60066258, 60068559, 60070835, 60070836, 60070837, 60074866, 60074955, 60074956, 60074959, 60075125, 60075170, 60080371, 60080372, 60080373, 60080374, 60080375, 60080376, 60081617, 60081618, 60081621, 60081622, 60081649, 60081650, 60081655, 60082887, 60083516, 60083519, 60084461, 60084462, 60084465, 60084466, 60084471, 60084472, 60084475, 60085739, 60085740, 60085741, 60085742, 60085743, 60085744, 60085745, 60086979, 60086980, 60086981, 60086982, 60086985, 60086986, 60088180, 60088181, 60088182, 60088183, 60088185, 60088186, 60089784, 60089785, 60089786, 60089787, 60089788, 60089789, 60091137, 60091138, 60091139, 60091140, 60091141, 60091142, 60092384, 60092407, 60092408, 60092409, 60092410, 60092412, 60093834, 60093835, 60093836, 60093839, 60093841, 60095438, 60095445, 60095446, 60095447, 60096697, 60096698, 60096699, 60096700, 60096701, 60096702, 60097821, 60097822, 60097823, 60097824, 60097825, 60098859, 60098860, 60098861, 60098863, 60098864, 60099739, 60099740, 60099741, 60099742, 60099743, 60099744, 60099745, 60101085, 60101086, 60101099, 60101100, 60101103, 60101104, 60102461, 60102462, 60102463, 60102464, 60102466, 60102467, 60102468, 60103937, 60103938, 60103939, 601039
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.