Class II U.S. Food and Drug Administration

American Contract Systems Inc. Medical convenience kits recall: Identified products were re-gassed (sterilized more than once) after

Recall published 1+ years ago

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

The hazard: Harmful chemical exposure

A chemical contaminant is behind this recall. The official notice names the substance, and that name is what a clinician or Poison Control will want to hear.

What the notice says: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

Why it matters: A chemical that should not be present at this level was found in the product. Depending on the substance, the concern may be a burn or irritation on contact, or a long-term risk from repeated exposure.

Symptoms and when to call a doctor

For a splash or spill, rinse the skin or eyes with running water for 15 to 20 minutes and remove contaminated clothing. If the product was swallowed, or if there is any trouble breathing, call Poison Control on 1-800-222-1222, which operates free and around the clock — or 911 if the person is collapsing, struggling to breathe or unconscious. Take the container or a photo of the label with you to any appointment.

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-0175-2026
Published
October 22, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
American Contract Systems Inc.
Product type
Medical devices
Units affected
32,433 total
Distribution
Nationwide
Made in
United States
Lot / code info
AMCL05P UDI-DI 191072207296 Lot 7990011 Bag serial no. N/A Lot 8170111 Bag serial numbers 68194152 68194153 68194160 68194176 68194179 68194182 68194190 Lot 8526511 Bag serial numbers 68873157 68874410; EVLH67F UDI-DI 191072232380 Lot 8211011 Bag serial number N/A Lot 8367311 Bag serial number 68570438; FDCL22R UDI-DI 191072185259 Lot 8048511 Bag serial numbers 68045373 68045376; IHCC03X UDI-DI 191072226273 Lot 80111 Bag serial number N/A Lot 8085711 Bag serial numbers 47506640 47506761; TNCC02AD UDI-DI 191072212757 Lot 7970911 Bag serial number N/A Lot 8045911 Bag serial number 47503192 Lot 8426711 Bag serial number 47886615; UICC27AG UDI-DI 191072231307 Lot 8085511 Bag serial number N/A Lot 8167611 Bag serial number 68194108; UIRD89AH UDI-DI 191072231314 Lot 8068111 Bag serial number 47499672 47499908 * if Bag serial number is "n/a", then all of that lot is affected
UPC codes
191072207296, 191072232380, 191072185259, 191072226273, 191072212757, 191072231307, 191072231314

Products covered by this recall

Medical convenience kits Item Number/Description EVLH67F LEFT HEART CATH PACK FDCL22R CATH LAB ANGIO IHCC03X CATH CARDIAC PACK TNCC02AD CARDIAC CATH TRINITY UICC27AG CARDIAC CATH ANGIO PACK (PS 923077) UIRD89AH RADIAL PACK (PS 56573)

Check your product

The notice names 13 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.

  • 191072207296
  • 191072232380
  • 191072185259
  • 191072226273
  • 191072212757
  • 191072231307
  • 191072231314

Lot or batch code

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

  • is affected — 32
  • 433 total

Serial number

On the rating plate, often next to the date of manufacture.

  • 68873157 68874410
  • 68045373 68045376
  • 47886615
  • 47499672 47499908

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 Chemical

American Contract Systems Inc. — A chemical contaminant is behind this recall. The official notice names the substance, and that name is what a clinician or Poison Control will want to hear.

  1. Stop using the product and keep it away from children and pets.
  2. Do not pour it down a drain or into a bin without checking local hazardous-waste rules, and never mix it with another cleaner.
  3. Ventilate the room if the product was sprayed or applied there.
  4. Keep the container — the lot code on it is what a refund claim and any medical follow-up both depend on.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • If the company stops responding, escalate to the CPSC. Firms under a recall order have reporting duties to the agency.
  • Have the model number, the date code and your photos ready. Many companies issue store credit by default — ask for cash or a card reversal if you would rather have it.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.

Company contact: American Contract Systems Inc. — 1601 Se Gateway Dr Ste 120, Grimes, IA, 50111-5223

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 American Contract Systems Inc. medical devices recalled?

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed. Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 191072207296, 191072232380, 191072185259; lot code is affected — 32, 433 total. 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 keep it away from children and pets.

Can I get my money back?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

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