Official recall notice
Presource Convenience Kits Recall (Sep 2026)
Product: Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15
- Recall date
- 2026-09-30
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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.
Affected products
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