FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corporation: Spectrum IQ Infusion pump, Product Code 357009
- Recall number
- Z-1810-2024
- Recalling firm
- Baxter Healthcare Corporation
- Product
- Spectrum IQ Infusion pump, Product Code 357009
- Status
- Open, Classified
- Initiated
- 2024-04-09
- Posted
- 2024-05-13
- Terminated
- not on file
- Reason
- There is a potential for cracks on the mount of the front panel of the device.
- Root cause
- Under Investigation by firm
- Action
- Baxter notified its consignees of the issue and requested an on-site inspection of the affected units on 04/09/2024 via telephone.
- Quantity
- 9 units
- Distribution
- US Nationwide distribution in the states of Ohio, Wisconsin.
- Lot, serial or model codes
- UDI/DI 00085412610900, Serial Numbers: 3770692, 3770755, 3770781, 3770816, 3770932, 3771122, 3771364, 3771374, 3771419
- 510(k) numbers
- ["K230041"]
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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