Class II U.S. Food and Drug Administration

Cardinal Health 200, LLC Presource Packs Containing Stryker StrykeFlow PS and Ahto recall: The kits contain tube sets with handpieces that may leak during use

Recall published 18 days ago

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.

The hazard: Fall or tip-over hazard

The recall is about structural failure — a frame, joint, leg or lock that does not hold under ordinary use.

What the notice says: The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.

Why it matters: The product can tip, collapse or give way under normal use. Furniture tip-overs in particular kill and injure young children, usually when a child climbs on an open drawer.

Symptoms and when to call a doctor

After a fall or a tip-over involving a child, watch for a headache that gets worse, repeated vomiting, drowsiness that is hard to rouse, confusion, unequal pupils, clear fluid from the nose or ear, or a seizure, and call 911 if any of these appear. Any fall onto the head in a baby under one, or any loss of consciousness at any age, needs to be assessed the same day.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-3295-2026
Published
October 7, 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
3677 kits
Distribution
Nationwide
Made in
United States
Lot / code info
1) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24309FG2 ; 2) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24352FG2 ; 3) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 24317FG2 ; 4) PGCGLCBAC, UDI-DI: 10197106751749(each), 50197106751747(case), Lot Number: 25062FG2 ; 5) PGCGLCBAD, UDI-DI: 10198956230309(each), 50198956230307(case), Lot Number: 25121FG2 ; 6) PGCGLCBAD, UDI-DI: 10198956230309(each), 50198956230307(case), Lot Number: 25045FG2 ; 7) PGCGLCBAE, UDI-DI: 10198956363366(each), 50198956363364(case), Lot Number: 25217FG2 ; 8) PGCGLCB11, UDI-DI: 10198956116177(each), 50198956116175(case), Lot Number: 24355FG2 ; 9) PV63CMST5, UDI-DI: 10198956526204(each), 50198956526202(case), Lot Number: 25148FG2 ; 10) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2 ; 11) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24325FG2 ; 12) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2 ; 13) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25029FG2 ; 14) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25069FG2 ; 15) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25045FG2 ; 16) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25069FG2 ; 17) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 24317FG2 ; 18) SBA23RBHNG, UDI-DI: 10197106417577(each), 50197106417575(case), Lot Number: 25085FG2 ; 19) SBA23RBHNH, UDI-DI: 10198956332010(each), 50198956332018(case), Lot Number: 25217FG2 ; 20) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25217FG2 ; 21) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25216FG2 ; 22) SBA30EDCLB, UDI-DI: 10198956286955(each), 50198956286953(case), Lot Number: 25274FG2 ; 23) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24325FG2 ; 24) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24309FG2 ; 25) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ; 26) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24348FG2 ; 27) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ; 28) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ; 29) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24354FG2 ; 30) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24354FG2 ; 31) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2 ; 32) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2 ; 33) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25055FG2 ; 34) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 24317FG2 ; 35) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25014FG2 ; 36) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25029FG2 ; 37) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 38) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 39) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 40) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25148FG2 ; 41) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25045FG2 ; 42) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25055FG2 ; 43) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25069FG2 ; 44) SLC37LCJOB, UDI-DI: 10887488326269(each), 50887488326267(case), Lot Number: 25148FG2 ; 45) SLC37LCJO…
UPC codes
10197106751749, 50197106751747, 10198956230309, 50198956230307, 10198956363366, 50198956363364, 10198956116177, 50198956116175, 10198956526204, 50198956526202, 10197106417577, 50197106417575, 10198956332010, 50198956332018, 10198956286955, 50198956286953, 10887488326269, 50887488326267

Products covered by this recall

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE , Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE , Catalog Number: PGCGLCBAE; 4) KIT, LAP CHOLE , Catalog Number: PGCGLCB11; 5) KIT, CARDIO MINIMALLY INVASIVE, Catalog Number: PV63CMST5; 6) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNG; 7) HMC ROBOTIC PACK , Catalog Number: SBA23RBHNH; 8) ENS ENDOCHOLEYCYSTECTOMIE 4 , Catalog Number: SBA30EDCLB; 9) LAP CHOLE PACK , Catalog Number: SLC37LCJOB; 10) LAP CHOLE PACK , Catalog Number: SLC37LCJ21; 11) LAP CHOLE PACK , Catalog Number: SLC37LCJ22; 12) PACK GYNE ROBOTIC , Catalog Number: SMA30RBHSA

Check your product

The notice names 49 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.

  • 10197106751749
  • 50197106751747
  • 10198956230309
  • 50198956230307
  • 10198956363366
  • 50198956363364
  • 10198956116177
  • 50198956116175
  • 10198956526204
  • 50198956526202
  • 10197106417577
  • 50197106417575
  • 10198956332010
  • 50198956332018
  • 10198956286955
  • 50198956286953
  • 10887488326269
  • 50887488326267

Lot or batch code

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

  • 24309FG2
  • 24352FG2
  • 24317FG2
  • 25062FG2
  • 25121FG2
  • 25045FG2
  • 25217FG2
  • 24355FG2
  • 25148FG2
  • 24325FG2
  • 25029FG2
  • 25069FG2
  • 25085FG2
  • 25216FG2
  • 25274FG2
  • 24348FG2
  • 24354FG2
  • 25055FG2
  • 25014FG2

Model or item number

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

  • PGCGLCBAC
  • PGCGLCBAD
  • PGCGLCBAE
  • PGCGLCB11
  • PV63CMST5
  • SBA23RBHNG
  • SBA23RBHNH
  • SBA30EDCLB
  • SLC37LCJOB
  • SLC37LCJ21
  • SLC37LCJ22
  • SMA30RBHSA — 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 Fall

Cardinal Health 200, LLC — The recall is about structural failure — a frame, joint, leg or lock that does not hold under ordinary use.

  1. Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.
  2. Anchor tall furniture to the wall with a tip-over restraint — this is worth doing for every chest and bookcase in the house, not just this one.
  3. Keep TVs, toys and anything else tempting off the top of tall furniture, because that is what draws a child to climb.
  4. Inspect similar units from the same range, since a weak joint or fastener usually affects a whole production run.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.

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 tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall. The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10197106751749, 50197106751747, 10198956230309; lot code 24309FG2, 24352FG2, 24317FG2; model number PGCGLCBAC, PGCGLCBAD, PGCGLCBAE. 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?

Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.

Can I get my money back?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Where was the recalled product sold?

It was distributed nationwide.

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