Class II U.S. Food and Drug Administration

Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within recall: The Urinary Catheter Trays contain CliniClean Pericare Wipes

Recall published last month

The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

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-3098-2026
Published
September 9, 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
2448 units
Distribution
Nationwide
Made in
United States
Lot / code info
1) PCVNCG540, UDI-DI: 10198956230057(each), 50198956230055(case), Lot Number: NGKT3319 ; 2) PCVNCG542, UDI-DI: 10198956312463(each), 50198956312461(case), Lot Number: NGKU0951 ; 3) PCVNCG55I, UDI-DI: 10197106283059(each), 50197106283057(case), Lot Number: NGKU0977 ; 4) PVCGBOB10, UDI-DI: 10198956219885(each), 50198956219883(case), Lot Number: NGKT2391 ; 5) PVCGBOB11, UDI-DI: 10198956220676(each), 50198956220674(case), Lot Number: NGKT2391 ; 6) PVCGBOB12, UDI-DI: 10198956256477(each), 50198956256475(case), Lot Number: NGKT2391 ; 7) PVCGBOB17, UDI-DI: 10198956393387(each), 50198956393385(case), Lot Number: NGKT2391 ; 8) PVCGOHCOH, UDI-DI: 10198956022270(each), 50198956022278(case), Lot Number: NGKT2391 ; 9) PVCGOHCPA, UDI-DI: 10197106666777(each), 50197106666775(case), Lot Number: NGKT3319 ; 10) PVCGOHCPA, UDI-DI: 10197106666777(each), 50197106666775(case), Lot Number: NGKT3319 ; 11) PVCGOHCPA, UDI-DI: 10197106666777(each), 50197106666775(case), Lot Number: NGKU0951 ; 12) PVHDCBAGK, UDI-DI: 10197106946473(each), 50197106946471(case), Lot Number: NGKT2391 ; 13) PVHDCBAGK, UDI-DI: 10197106946473(each), 50197106946471(case), Lot Number: NGKT2391 ; 14) PVHDCBAGK, UDI-DI: 10197106946473(each), 50197106946471(case), Lot Number: NGKT2391 ; 15) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 16) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 17) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKW2687 ; 18) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 19) PVHDCGVCP, UDI-DI: 10198956254596(each), 50198956254594(case), Lot Number: NGKV2393 ; 20) PVHDCGV40, UDI-DI: 10198956326941(each), 50198956326949(case), Lot Number: NGKV2393 ; 21) PVHDVAAGH, UDI-DI: 10197106946459(each), 50197106946457(case), Lot Number: NGKT2391 ; 22) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKV2393 ; 23) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKV2393 ; 24) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKW2687 ; 25) PVHDVPVCQ, UDI-DI: 10198956254619(each), 50198956254617(case), Lot Number: NGKW2687 ; 26) PVHDVPV43, UDI-DI: 10198956354838(each), 50198956354836(case), Lot Number: NGKW2687 ; 27) PVOCMGJ36, UDI-DI: 10198956248663(each), 50198956248661(case), Lot Number: NGKT2391 ; 28) PVOCOHNHE, UDI-DI: 10198956071940(each), 50198956071948(case), Lot Number: NGKT2391 ; 29) PVOCOHNHE, UDI-DI: 10198956071940(each), 50198956071948(case), Lot Number: NGKT2391 ; 30) PVOCOHNHE, UDI-DI: 10198956071940(each), 50198956071948(case), Lot Number: NGKT2455 ; 31) PVOCOH12O, UDI-DI: 10198956202054(each), 50198956202052(case), Lot Number: NGKT2391 ; 32) PVVMCV07E, UDI-DI: 10198956179615(each), 50198956179613(case), Lot Number: NGKT2394 ; 33) PVVMFP22R, UDI-DI: 10198956179653(each), 50198956179651(case), Lot Number: NGKT2394 ; 34) PVVMFP245, UDI-DI: 10198956249141(each), 50198956249149(case), Lot Number: NGKT2394 ; 35) PVVMTH22J, UDI-DI: 10198956119314(each), 50198956119312(case), Lot Number: NGKU0856 ; 36) PVVMTH22J, UDI-DI: 10198956119314(each), 50198956119312(case), Lot Number: NGKU0957 ; 37) PVVMTH22J, UDI-DI: 10198956119314(each), 50198956119312(case), Lot Number: NGKU0856 ; 38) PVVMTO22R, UDI-DI: 10198956161016(each), 50198956161014(case), Lot Number: NGKT2394 ; 39) PVVMTO241, UDI-DI: 10198956221741(each), 50198956221749(case), Lot Number: NGKT2394 ; 40) PVVMTO242, UDI-DI: 10198956300521(each), 50198956300529(case), Lot Number: NGKT2394 ; 41) PVVXTHLCG, UDI-DI: 10198956170759(each), 50198956170757(case), Lot Number: NGKT1789 ; 42) PVV2CC10R, UDI-DI: 10198956285262(each), 50198956285260(case), Lot Number: NGKV3390 ; 43) PVV2CC10S, UDI-DI: 10198956346611(each), 50198956346619(case), Lot Number: NGKV3390 ; 44) PVV2CC10S, UDI-DI: 10198956346611(each), 50198956346619(case), Lot Number: NGKV2390 ; 45) PVV2MJ01M, UDI-DI: 10198956285224(each), 501…
UPC codes
10198956230057, 50198956230055, 10198956312463, 50198956312461, 10197106283059, 50197106283057, 10198956219885, 50198956219883, 10198956220676, 50198956220674, 10198956256477, 50198956256475, 10198956393387, 50198956393385, 10198956022270, 50198956022278, 10197106666777, 50197106666775, 10197106946473, 50197106946471

Products covered by this recall

Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG540; 2) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG542; 3) KIT, GVI OPEN HEART A B , Catalog Number: PCVNCG55I; 4) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB10; 5) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB10; 6) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB12; 7) KIT, BLO BASIC OPEN HEART , Catalog Number: PVCGBOB17; 8) KIT, OPEN HEART CON , Catalog Number: PVCGOHCOH; 9) KIT,OPEN HEART ADULT MDST , Catalog Number: PVCGOHCPA; 10) KIT, CABG , Catalog Number: PVHDCBAGK; 11) KIT, ORP CABG , Catalog Number: PVHDCGVCP; 12) KIT, ORP CABG , Catalog Number: PVHDCGV40; 13) KIT, VALVE , Catalog Number: PVHDVAAGH; 14) KIT, ORP VALVE , Catalog Number: PVHDVPVCQ; 15) KIT, ORP VALVE , Catalog Number: PVHDVPV43; 16) KIT, MAJOR CARDIAC , Catalog Number: PVOCMGJ36; 17) KIT, OPEN HEART DH , Catalog Number: PVOCOHNHE; 18) KIT, OPEN HEART , Catalog Number: PVOCOH12O; 19) KIT, CAROTID ENDARTERECTOMY , Catalog Number: PVVMCV07E; 20) KIT, FEM POP BARNES JEW , Catalog Number: PVVMFP22R; 21) KIT, FEM POP BARNES JEW , Catalog Number: PVVMFP245; 22) KIT, THORACIC BARNES JEWISH , Catalog Number: PVVMTH22J; 23) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO22R; 24) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO241; 25) KIT, THORACIC OUTLET SYNDROME , Catalog Number: PVVMTO242; 26) KIT, THORACIC , Catalog Number: PVVXTHLCG; 27) KIT,OPEN HEART BASIC PRESBYTER, Catalog Number: PVV2CC10R; 28) KIT,OPEN HEART BASIC PRESBYTER, Catalog Number: PVV2CC10S; 29) KIT, MAJOR VASC, PRESBYTERIAN , Catalog Number: PVV2MJ01M; 30) KIT, CARDIAC VALVE , Catalog Number: PVV207962; 31) KIT, CARDIAC VALVE , Catalog Number: PVV207963; 32) KIT, CARDIAC VALVE , Catalog Number: PVV207964; 33) KIT, CARDIAC CABG , Catalog Number: PVV293340; 34) KIT, CARDIAC CABG , Catalog Number: PVV293362; 35) KIT, CARDIAC CABG , Catalog Number: PVV293363; 36) KIT, PUH CARDIAC CABG , Catalog Number: PVX4CAP14; 37) KIT, PUH CARDIAC , Catalog Number: PVX4CRPR7; 38) KIT, EAS THORACIC ABDOMINAL , Catalog Number: PVX4THEAA; 39) KIT, CV , Catalog Number: PV15CGSPF; 40) KIT, CV , Catalog Number: PV15CGSPG; 41) KIT,MAJOR VASCULAR , Catalog Number: PV15MJSPD; 42) KIT, OPEN HEART SET UP , Catalog Number: PV24OHN29; 43) KIT, OPEN HEART , Catalog Number: PV29OHMME; 44) KIT, OPEN HEART , Catalog Number: PV3LOHSGJ; 45) KIT, MER THORACOTOMY CHEST , Catalog Number: PV33TCMYB; 46) KIT, MER THORACOTOMY CHEST , Catalog Number: PV33TCMY3; 47) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR47; 48) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR48; 49) KIT, BASIC OPEN HEART , Catalog Number: PV40OHAR49; 50) KIT, OPEN HEART , Catalog Number: PV40OHJUD; 51) KIT, MODULE OPEN HEART , Catalog Number: PV60OH15F; 52) CV W AUX PACK 2 OF 2 CMC , Catalog Number: SCVCGPAACD; 53) THORACIC ROBOTIC PACK CMC , Catalog Number: SCVCGTRACI; 54) CV PACK 2 OF 2 GSH , Catalog Number: SCVCGVCG17; 55) CV PACK 2 OF 2 GSH , Catalog Number: SCVCGVCG18; 56) CV PACK 2 OF 2 SHER , Catalog Number: SCVCGVCS16

Check your product

The notice names 53 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.

  • 10198956230057
  • 50198956230055
  • 10198956312463
  • 50198956312461
  • 10197106283059
  • 50197106283057
  • 10198956219885
  • 50198956219883
  • 10198956220676
  • 50198956220674
  • 10198956256477
  • 50198956256475
  • 10198956393387
  • 50198956393385
  • 10198956022270
  • 50198956022278
  • 10197106666777
  • 50197106666775
  • 10197106946473
  • 50197106946471

Lot or batch code

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

  • NGKT3319
  • NGKU0951
  • NGKU0977
  • NGKT2391
  • NGKV2393
  • NGKW2687
  • NGKT2455
  • NGKT2394
  • NGKU0856
  • NGKU0957
  • NGKT1789
  • NGKV3390
  • NGKV2390

Model or item number

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

  • PCVNCG540
  • PCVNCG542
  • PCVNCG55I
  • PVCGBOB10
  • PVCGBOB12
  • PVCGBOB17
  • PVCGOHCOH
  • PVCGOHCPA
  • PVHDCBAGK
  • PVHDCGVCP
  • PVHDCGV40
  • PVHDVAAGH
  • PVHDVPVCQ
  • PVHDVPV43
  • PVOCMGJ36
  • PVOCOHNHE
  • PVOCOH12O
  • PVVMCV07E
  • PVVMFP22R
  • PVVMFP245

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 — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

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 Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation. The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10198956230057, 50198956230055, 10198956312463; lot code NGKT3319, NGKU0951, NGKU0977; model number PCVNCG540, PCVNCG542, PCVNCG55I. 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?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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