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Baxter SIGMA Spectrum Infusion Pump with Master Drug… recallZ-0122-2021 · Baxter Healthcare Corporation · initiated Jun 30, 2020

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Baxter is updating the device IFU for safety communication regarding cleaning practices.

FDA root cause category: Labeling design

What the company is doing

A Safety Alert communication was sent to affected customers on 04/01/2020 via USPS First Class Mail. A follow-up Urgent Device Correction communication was sent to all affected customers on 8/28/2020 via USPS first class mail. The customer communications reiterate instructions for use listed in the Operator's Manual. Baxter is asking customers to: 1) Operators may continue to safely use the infusion pumps while following the instructions for cleaning provided in the Operator's Manual. An electronic copy of the Operator's Manual can be accessed at https://service.baxter.com. In addition, a full list of approved cleaning agents can be accessed at www.spectrumIQ.com/resources.html. 2) Inspect all pumps at their facility to assess the electrical pins on the pump rear case and the battery electrical contacts for residue buildup or corrosion. If corrosion or residue buildup is identified, please contact Baxter to service the device. 3) Baxter will be updating the Instructions for Use to recommend a routine inspection process for the electrical pins on the pump rear case and the battery electrical contacts. Once the updated Instructions for Use are made available, Baxter will issue a written notification to inform customers of the availability of the updated IFU. The updated IFU may be accessed online at the Baxter Global Technical E Service Center at URL: https://service.baxter.com. 4) Clinicians should ensure backup devices are readily available when infusing critical medications where interruptions could cause serious injury or death. 5) To maintain the battery properly, please ensure the pumps are plugged into AC power when possible to prevent battery depletion. 6) Complete the enclosed customer reply form and return it to Baxter by email. On 9/22/2021, the firm issued an Urgent Device Correction letter dated 9/22/2021 in follow-up to their communication of the 4/1/2020 safety alert and 8/28/2020 Urgent Device Correction. This was issued via first class USPS ma

Recall details

Recall number
Z-0122-2021
Status
Terminated
Initiated by the company
Jun 30, 2020
Posted by the FDA
Oct 22, 2020
Recalling firm
Baxter Healthcare Corporation
Quantity
152,539 units
Product code
FRN
FDA submissions
K133801
Distribution
Distribution throughout the United States, St. Thomas USVI, and Puerto Rico. Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)

Product description

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

Code information (models, lots, serial numbers)

Product Code: 35700BAX2, All Serial Numbers; GTIN 00085412498683

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 86062).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page