FDAClass IIJuly 6, 2016

PrismaSate BGK2/0 Dialysis Solution for Continuous recall

PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy

Why was PrismaSate BGK2/0 Dialysis Solution for Continuous recalled?

Presence of leaks near top of the PrismaSate bags

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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).

Product
PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Recalling firm
Baxter Healthcare Corp.
Quantity
10,054 units
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
Recall date
July 6, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls