Device product
EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Z-0367-2019
Product summary
- Event
- Event 81240
- Status
- Terminated
- Classification
- Class II
- Quantity
- 281,350 units
- Official record key
device-enforcement:Z-0367-2019
Official wording
Reason: Potential ability to leak once used for compounding.
Code information: Product Code H938741 Lot #'s: 60056339, 60066281, 60066284, 60066289, 60073320, 60099757, and 60103967. **Update expansion on 02/19/2019 additional lot numbers: 60055892, 60064600, 60078408, 60091166, 60094120, 60094126, 60099759, 60101131, 60101132, 60101135, 60101136, 60102485, 60103966, 60105206, 60105404, 60106918, 60117111, 60117113, 60117116, 60120934, 60120936, 60120938, 60120939, 60122729, 60122730, 60122731, 60128813, 60128814, 60128815, 60131891, 60132230, 60132231.
Distribution pattern: Worldwide distribution - US Nationwide in 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, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. Countries of Canada, Australia, New Zealand, China, Hong Kong, Brazil, Chile, and Uruguay.
Derived failure modes
-
Unknown
Potential ability to leak once used for compounding.