Recalls / —

—#180772

Product

Prismaflex Control Unit

FDA product code

KDI — Dialyzer, High Permeability With Or Without Sealed Dialysate System

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K131516

Affected lot / code info

Product Code: 114870; Lot Number: PA18198, PA18199, PA18238, PA22556, PA22558.

Why it was recalled

Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Baxter notified customers on about 04/07/2020 via "URGENT MEDICAL DEVICE RECALL" letter. The letter instructed customers that the affected units can still be used until the replacement is performed, a local Baxter representative will contact each facility to schedule the replacement of affected devices, complete and return the Baxter Customer Reply Form by scanning and e-mailing it to perezd2@baxter.com, and if the affected devices have been further distributed, to please notify those customers by forwarding a copy of the recall notification. For general questions, contact Baxter Customer Service at 787 866 70 27, between the hours of 7:00 am to 4:00 pm local time, Monday through Friday.

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

Distribution only to Puerto Rico and Guam

Timeline

Recall initiated

2020-04-07

Terminated

2021-11-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #180772. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.