FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
- Recall number
- Z-0120-2021
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
- Status
- Terminated
- Initiated
- 2020-06-30
- Posted
- 2020-10-22
- Terminated
- 2024-04-29
- Reason
- Baxter is updating the device IFU for safety communication regarding cleaning practices.
- Root cause
- Labeling design
- Action
- 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
- Quantity
- 9352 units
- 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)
- Lot, serial or model codes
- Product Code: 35700ABB, All Serial Numbers; GTIN 00085412091570
- 510(k) numbers
- ["K042121"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28