Recall Z-0971-2018— Baxter Healthcare Corporation

Name: FDA recall Z-0971-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-06

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2017-10-06, terminated 2019-04-11. It names one FDA 510(k) clearance: K133801. Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.. Reason: Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-10-06
Terminated: 2019-04-11
Firm location: Medina, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K133801 — BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARYBaxter Healthcare Corporation·cleared 2014-05-07

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

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. Intended to be used for the controlled administration of fluids.

Reason for recall

Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.

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