Recall Z-2049-2016— Baxter Healthcare Corp.

Name: FDA recall Z-2049-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-23

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2016-05-23, terminated 2017-03-28. It names one FDA 510(k) clearance: K072908. Product: PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy. Reason: Presence of leaks near top of the PrismaSate bags.

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-05-23
Terminated: 2017-03-28
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K072908 — PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYGambro Renal Products·cleared 2008-02-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy

Reason for recall

Presence of leaks near top of the PrismaSate bags

Data sourced from openFDA. This site is unofficial and independent of the FDA.