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Recall

Medline Industries, LP: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908 Recall

Unapproved design changes to the products outside of the 510(k) clearance. Product details: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D

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Agency
FDA
Record ID
Z-1885-2026
Canonical
https://claimwatch-mvp.vercel.app/item/medline-industries-lp-medline-convenience-kits-containing-select-skus-of-10ml-polycarbonat/

What happened?

Unapproved design changes to the products outside of the 510(k) clearance. Product details: Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK DYNJ908706D

Who may be affected?

Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.

What should consumers do?

Affected quantity: 270,311 total

Official source

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