Recall Z-0081-2023— Baxter Healthcare Corporation

Name: FDA recall Z-0081-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-14

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-09-14. It names one FDA 510(k) clearance: K041005. Product: Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.. Reason: Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-09-14
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K041005 — GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETSGambro Renal Products·cleared 2004-10-07

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

Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.

Reason for recall

Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.

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