Device recall
Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15
- Recall number
- Z-3255-2026
- Event id
- 99710
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Report date
- Sep 30, 2026
- Posted
- Sep 22, 2026
- Initiated
- Aug 10, 2026
- Center classification date
- Sep 22, 2026
- Product code
- OWL
- Device type
- Peripheral Catheter Insertion Kit
- 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.
- Root cause
- Nonconforming Material/Component
- Quantity
- 9480 kits
- Code info
- 1) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 20 ; 2) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398 ; 3) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398 ; 4) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5129488 ; 5) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074 ; 6) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074 ; 7) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5182660 ; 8) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103 ; 9) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5126398 ; 10) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5181074 ; 11) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103 ; 12) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188102 ; 13) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5199118 ; 14) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5188103 ; 15) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5195818 ; 16) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5150160 ; 17) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5195818 ; 18) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5210853 ; 19) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5248375 ; 20) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5276968 ; 21) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5350797 ; 22) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5279226 ; 23) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5350797 ; 24) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5307185 ; 25) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 5310701 ; 26) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 6051588 ; 27) PVMHIVM14, UDI-DI: 10198956165434(each), 50198956165432(case), Lot Number: 5126398 ; 28) PVMHIVM15, UDI-DI: 10198956184459(each), 50198956184457(case), Lot Number: 5129058
- Distribution
- US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Waukegan, IL, United States