medical MODERATE Updated 2026-09-02

AVID Medical, Inc. recalls Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE

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Recalled Product

Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27

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Hazard / Issue

Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Code: Lot Number: 1634391 UDI: 10809160439708

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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