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

This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

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-0180-2026
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
ANCA80AP UDI-DI 191072232168 Lot 8077111 Bag serial number 68119740; HSAN63N UDI-DI 191072232267 Lot 8097211 Bag serial number N/A; IHAN02W UDI-DI 191072201928 Lot 7961811 Bag serial number 68086881 Lot 8037411 Bag serial number N/A; MHCA98AK UDI-DI 191072216014 Lot 8006711 Bag serial number 47415134 Lot 8133011 Bag serial number N/A; RCAN45C UDI-DI 191072229632 Lot 8537111 Bag serial number 68872542; UDCO10F UDI-DI 191072216236 Lot 7987811 Bag serial number N/A * If bag serial number is listed as "N/A", then whole lot is affected
UPC codes
191072232168, 191072232267, 191072201928, 191072216014, 191072229632, 191072216236

Products covered by this recall

Medical convenience kits Item Number/Description HSAN63N ANGIO PACK IHAN02W ANGIOGRAPHY PACK MHCA98AK CORONARY ANGIO PACK- 205991 RCAN45C ANGIO CUSTOM RCH UDCO10F CVL CORONARY PACK 219224

Check your product

The notice names 10 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.

  • 191072232168
  • 191072232267
  • 191072201928
  • 191072216014
  • 191072229632
  • 191072216236

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.

  • 68119740
  • 68872542

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. — This notice concerns a chemical found in the product at a level regulators consider unsafe, which is usually caught by laboratory testing rather than by anybody noticing a problem.

  1. Stop using the product and keep it away from children and pets.
  2. Ventilate the room if the product was sprayed or applied there.
  3. Keep the container — the lot code on it is what a refund claim and any medical follow-up both depend on.
  4. If anyone has symptoms, call Poison Control on 1-800-222-1222 rather than guessing.

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.
  • 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.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.

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 191072232168, 191072232267, 191072201928; 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?

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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