Recall Z-1817-2022— Baxter Healthcare Corporation

Name: FDA recall Z-1817-2022
Creator: U.S. Food and Drug Administration
Published: 2022-09-02

Class III · Ongoing

Class III FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-09-02. It names one FDA 510(k) clearance: K083093. Product: 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.. Reason: Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards..

Recalling firm: Baxter Healthcare Corporation
Classification: Class III
Status: Ongoing
Initiated: 2022-09-02
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K083093 — CHEETAH RELIANTCheetah Medical, Inc.·cleared 2008-12-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.