PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corp. is recalling 10,054 units of PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy due to the presence of leaks near the top of the bags. The affected product was distributed to Columbia and numerous U.S. states including Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.
The recalled units include lot codes 1000123133 (expiration date 02/28/2017), 1000128162 (expiration date 04/30/2017), 1000128163 (expiration date 04/30/2017), and 1000128164 (expiration date 04/30/2017), identified by product code #105351 and Unique Device Identifier #07332414037048. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Presence of leaks near top of the PrismaSate bags
Reason for recall: Presence of leaks near top of the PrismaSate bags Distribution: 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 Quantity: 10,054 units Lot/code info: 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).
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.