Recall Z-0672-2017— Baxter Healthcare Corp.

Name: FDA recall Z-0672-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-28

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2016-09-28, terminated 2018-06-15. It names one FDA 510(k) clearance: K133801. Product: V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended. Product Code 35701 is a replacement assembly that is shipped to customers for self-repair of the Spectrum Infusion Pump. It is not a registered finished good.. Reason: A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-09-28
Terminated: 2018-06-15
Firm location: Deerfield, IL, 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

V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended. Product Code 35701 is a replacement assembly that is shipped to customers for self-repair of the Spectrum Infusion Pump. It is not a registered finished good.

Reason for recall

A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library and Rear Case Assembly in order to replace speakers installed in pumps or included in spare part rear case assemblies that have an increased potential to fail prematurely.

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