Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV
Summary
The FDA issued a Class II for Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: by Cardinal Health 200, LLC. Reason: The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applica.
Details
Source
Device Recall
External ID
Z-3255-2026
Action Date
2026-09-30
Status
Ongoing
Category
device
Product Description
Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15
Lot/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
Quantity Affected: 9480 kits
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.
Distribution
US Nationwide distribution in the states of FL, KY, MO, NC, OH, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-10
Company
Waukegan, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 196 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Cardinal Health 200, LLC has 164 FDA actions in our database, including 163 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health 200, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health 200, LLC have FDA actions?
Cardinal Health 200, LLC has 164 FDA actions in our database, including 163 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3255-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29