Class II U.S. Food and Drug Administration

Cardinal Health 200, LLC Presource Convenience Kits: 1) KIT, Usgpiv recall: The kits contain applicators that may exhibit an open or incomplete seal

Recall published 25 days ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-3255-2026
Published
September 30, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Cardinal Health 200, LLC
Product type
Medical devices
Units affected
9480 kits
Distribution
Nationwide
Made in
United States
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
UPC codes
10197106488959, 50197106488957, 10198956165434, 50198956165432, 10198956184459, 50198956184457

Products covered by this recall

Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15

Check your product

The notice names 28 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10197106488959
  • 50197106488957
  • 10198956165434
  • 50198956165432
  • 10198956184459
  • 50198956184457

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 20
  • 5126398
  • 5129488
  • 5181074
  • 5182660
  • 5188103
  • 5188102
  • 5199118
  • 5195818
  • 5150160
  • 5210853
  • 5248375
  • 5276968
  • 5350797
  • 5279226
  • 5307185
  • 5310701
  • 6051588
  • 5129058 — 9480 kits

Model or item number

On the rating label, the box or the instruction sheet.

  • PVMHIVMHD
  • PVMHIVM14
  • PVMHIVM15 — 1

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Cardinal Health 200, LLC — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Cardinal Health 200, LLC — 3651 Birchwood Dr, Waukegan, IL, 60085-8337

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Cardinal Health 200, LLC medical devices recalled?

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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10197106488959, 50197106488957, 10198956165434; lot code 20, 5126398, 5129488; model number PVMHIVMHD, PVMHIVM14, PVMHIVM15 — 1. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls