FDA-Device2026-09-30Class IIPACKAGING DEFECT

Cardinal Health Presource Convenience Kits recalled for potentially contaminated applicators

OTHERNationwide distributionMedical devices

What this means

Cardinal Health Presource Convenience Kits contain applicators with packaging that may have an open or incomplete seal. If an applicator becomes contaminated, it could cause a localized skin or soft tissue infection, or in rare cases, a more serious infection.

Check your medical supply inventory for affected kit catalog numbers (AMN548616A, BA1DH0116B, IVSJV8302E, IVS3223531–IVS3223535, and others listed in the recall).
Do not use applicators from affected kits if the packaging appears open or damaged.
Contact Cardinal Health or your healthcare facility for instructions on replacement or disposal.
Report any infections or adverse effects to your healthcare provider.

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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

All ages

Illnesses reported

None reported

Sold states

US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.

Affected count

17503 kits

Manufactured in

3651 Birchwood Dr, Waukegan, IL, United States

Products

Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE , Catalog Number: IVSJV8302E; 4) KIT, IV SUPPLIES , Catalog Number: IVS3223531; 5) KIT, IV SUPPLIES , Catalog Number: IVS3223532; 6) KIT, IV SUPPLIES , Catalog Number: IVS3223533; 7) KIT, IV SUPPLIES , Catalog Number: IVS3223534; 8) KIT, IV SUPPLIES , Catalog Number: IVS3223535; 9) KIT, IV SUPPLIES , Catalog Number: IVS322358M; 10) KIT, IV SUPPLIES , Catalog Number: IVS322358N; 11) KIT, IV SUPPLIES , Catalog Number: IVS322358O; 12) KIT, PATIENT ADMISSIONS , Catalog Number: AMN333032A; 13) KIT, C SECTION , Catalog Number: MAT42267AL; 14) KIT, C SECTION , Catalog Number: MAT4226725; 15) KIT, VAGINAL DELIVERY , Catalog Number: MAT422677G; 16) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226792; 17) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226793; 18) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226794; 19) KIT, VAGINAL DELIVERY , Catalog Number: MAT4226795

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3254-2026

More Cardinal Health recalls

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