Home / Recalls / Baxter Healthcare Corp. / Z-0671-2017

Z-0671-2017 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
December 7, 2016
Initiation Date
September 28, 2016
Termination Date
June 15, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15,517 units (US: 9560; Canada: 5957)

Product Description

Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporation, 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.

Reason for Recall

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

Distribution Pattern

Nationwide Distribution, Puerto Rico and Canada

Code Information

Contact CDRH for list of affected serial numbers (15,517).

Other recalls by Baxter Healthcare Corp.

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  • Z-0670-2017 Class II — sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum In (September 28, 2016)
  • Z-0672-2017 Class II — V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spec (September 28, 2016)
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  • Z-2049-2016 Class II — PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy (May 23, 2016)
  • Z-1838-2016 Class II — COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular rec (May 12, 2016)
  • Z-1839-2016 Class II — COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular re (May 12, 2016)
  • Z-1840-2016 Class II — COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular re (May 12, 2016)
  • Z-1629-2016 Class II — GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754 (April 21, 2016)