Reported Oct 5, 2022 · Ongoing

Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and…

Baxter Healthcare Corporation

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

3 of 3 products

Products covered by this recall
Model / numberProduct as published
CMM-ST5Starling Monitor, Product code CMMST5 and Starling Monitor SV, (same products)
and accessories/spare parts Starling Battery Pack, Product Code CMABATT
CMASC10.and Starling Patient Cable
Lot codes and dates

5 of 5 products

Products covered by this recall
Model / numberBarcodesProduct as published
CMMST57290013030269All serial numbers after 6/2016. - Incorrect UDI-DI: 7290013030269
CMM-ST5072900130302697290013030030correct UDI-DI: 07290013030269. - Incorrect UDI-DI: 7290013030030
072900130300307290013030160correct UDI-DI: 07290013030030. Product code CMABATT - Incorrect UDI-DI: 7290013030160
CMASC10072900130301607290013030054correct UDI-DI: 07290013030160. - Incorrect UDI-DI: 7290013030054
07290013030054correct UDI-DI: 07290013030054.
Amount recalled
9,671 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:48 PM UTC

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