FDA Device recall Z-3255-2026
Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD by Cardinal Health 200, citing 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 patien….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3255-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-10 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
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.
Identifiers
| code_info | 1) PVMHIVMHD, UDI-DI: 10197106488959(each), 50197106488957(case), Lot Number: 20 ; 2) PVMHIV…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) PVMHIV |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Cardinal Health 200
- Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU
FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC
FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC
FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A
FDA Device · Class II · 2026-09-30 · Cardinal Health 200
All Cardinal Health 200 recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3255-2026%22
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