Recall Z-3255-2026— Cardinal Health 200, LLC
Class II · Ongoing
Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2026-08-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15. Reason: 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..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-10
- Firm location
- Waukegan, IL, United States
Product description
Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.