FDA-Device2026-09-30Class IIPACKAGING DEFECT

Cardinal Health Presource Convenience Kits recalled for unsealed applicator packaging contamination risk

OTHERNationwide distributionMedical devices

What this means

Cardinal Health Presource Convenience Kits contain applicators with potentially open or incomplete seals on their packaging. If a contaminated applicator is used, it could cause a localized skin or soft tissue infection, or in rare cases, a more serious systemic infection.

  • Check your kits against the affected lot numbers listed in the FDA notice
  • Do not use applicators from recalled kits
  • Contact your healthcare provider or Cardinal Health if you have questions
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The agency's original wording
Hazard

The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur.

Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.
Affected count
9480 kits
Manufactured in
3651 Birchwood Dr, Waukegan, IL, United States
Products
Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3255-2026

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