Halyard recalls DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR with statlock due to latex labeling deficiency. Affected units may cause allergic reactions.
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Halyard is recalling DAVINCI TRUCUSTOM BUNDLE products with TRAY FOLEY 16FR and statlock components because the labeling doesn't identify natural rubber latex. This could cause allergic reactions in people sensitive to latex.
The labeling fails to state that the statlock contains natural rubber latex. This means users might not know they could have an allergic reaction if they're sensitive to latex.
People using medical kits with natural rubber latex may be at risk of allergic reactions. Those with latex allergies are most affected.
Check for the model number SAMM064-27 and lot number 1634391 on the product. The product includes TRAY FOLEY 16FR with a statlock component.
Review the product label for natural rubber latex content if you have latex allergies.
The product may cause allergic reactions in people sensitive to natural rubber latex, so it's not safe for those with latex allergies.
If you have latex allergies, stop using this product and contact Halyard for alternatives.
Look for the model number SAMM064-27 and lot number 1634391 on the product.
We’ve drafted a message you can send Halyard to request your refund or repair — edit it as you like.
Subject: Recall Z-3005-2026 — Halyard Halyard Hello, I own a Halyard that is covered by recall Z-3005-2026 from Halyard. 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.
