Baxter Healthcare recalls Starling Monitors with incorrect UDI labeling that fails GS-1 standards. Affected units have serial numbers after June 2016. No immediate safety risk but may cause compliance problems with medical device tracking systems.
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
Baxter Healthcare is recalling Starling Monitors and related parts that have incorrect Unique Device Identification (UDI) labels. This labeling error means the products don't meet GS-1 standards for medical device tracking, which could cause compliance issues with regulatory systems but does not pose a direct safety risk to users.
The UDI labels on these monitors have incorrect or incomplete information, specifically missing the leading zero in the Unique Device Identification (UDI) number. This makes the labels non-compliant with GS-1 standards, which are required for proper medical device tracking. The issue does not cause physical harm but could lead to regulatory compliance problems in healthcare settings.
Healthcare facilities using Starling Monitors with serial numbers after June 2016 are affected. Medical device staff and patients using these monitors may be at risk of compliance issues with regulatory tracking systems.
Check the serial number on the monitor or accessories. Products with serial numbers after June 2016 are affected. The UDI label shows incorrect numbers without the leading zero (e.g., 7290013030269 instead of 07290013030269).
Look for the Unique Device Identification (UDI) number on the monitor or accessories. Affected units have serial numbers after June 2016 and show incorrect UDI labels without the leading zero.
No, the labeling error does not cause physical harm but may lead to compliance issues with medical device tracking systems.
Check the UDI label for the correct format. If the serial number is after June 2016 and the UDI label lacks a leading zero, contact Baxter Healthcare for guidance.
Look for the serial number on the monitor or accessories. Products with serial numbers after June 2016 and incorrect UDI labels (e.g., 7290013030269 instead of 07290013030269) are affected.
We’ve drafted a message you can send Baxter Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1817-2022 — Baxter Healthcare Baxter Healthcare Hello, I own a Baxter Healthcare that is covered by recall Z-1817-2022 from Baxter Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
