Device product
PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Z-2049-2016
Product summary
- Event
- Event 74226
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,054 units
- Official record key
device-enforcement:Z-2049-2016
Official wording
Reason: Presence of leaks near top of the PrismaSate bags
Code information: Listing #D051124, Unique Device Identifier #07332414037048, Product code #105351. Lot code (Exp date): 1000123133 (02/28/2017), 1000128162 (04/30/2017), 1000128163 (04/30/2017), 1000128164 (04/30/2017).
Distribution pattern: Distributed to Columbia and the following US states: AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI
Derived failure modes
-
Unknown
Presence of leaks near top of the PrismaSate bags