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Lower risk Medical device recall · FDA · Published October 6, 2017

Baxter Healthcare Corporation - 720000-720000

Baxter Healthcare Corporation - 720000-720000

🇺🇸 FDA recall #Z-0971-2018Medical deviceBaxter Healthcare Corporation ›
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Contact the company

Recalling firmBaxter Healthcare Corporation711 Park Ave · Medina, NY 14103-1036
✎ GovInfoNow plain-language explainer

What happened, in plain English

Baxter Healthcare Corporation - 720000-720000 Read more at govinfonow.com/recall/72892-baxter-healthcare-corporation-720000-720000.

Source Summary by GovInfoNow · govinfonow.com/recall/72892-baxter-healthcare-corporation-720000-720000 · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0971-2018

Cite this page

“Baxter Healthcare Corporation - 720000-720000.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/72892-baxter-healthcare-corporation-720000-720000. Based on FDA recall #Z-0971-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0971-2018%22&limit=1).

Why it’s dangerous

Baxter Healthcare Corporation

Who’s affected

Baxter Healthcare Corporation

How to tell if you have this one

Baxter Healthcare Corporation

  • Brand
    Baxter Healthcare Corporation
  • Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. 1

    Baxter Healthcare Corporation

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Worldwide Distribution - US, including the District of Columbia, Puerto Rico, and Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

1. Firm started the recall: Oct 6, 201712. FDA classified it Class II: Mar 12, 201823. Published in FDA’s Enforcement Report: Mar 21, 201834. FDA terminated the recall: Apr 11, 2019420172019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0971-2018 (October 6, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0971-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA