Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1817-2022 — Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.

U.S. FDA — Device Enforcement · United States · 2022-09-02 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1817-2022
Date of alert: 2022-09-02
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Baxter Healthcare Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 7290013030269

Reported risk: Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1817-2022 — Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product Code CMABATT; and Starling Patient Cable, Product code CMASC10.

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