Class II U.S. Food and Drug Administration

American Contract Systems, Medical Procedure kits and trays labeled recall: During an internal investigation, ACS determined that the rationale

Recall published 1+ years ago

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

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-2464-2025
Published
September 3, 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
31506 units
Distribution
Illinois, Louisiana
Made in
United States
Lot / code info
1) MODEL/ITEM NUMBER ANCV78BC: UDI/DI 00191072235169, Kit Lot Numbers: 42-7844511, 42-8133811, 42-8037211, 42-7952411, 42-7882011; 2) MODEL/ITEM NUMBER ANVA82AB: UDI/DI 00191072235183, Kit Lot Numbers: 42-8025011, 42-8108511, 42-7928511; 3) MODEL/ITEM NUMBER BHOP48O: UDI/DI 00191072221490, Kit Lot Numbers: 9207467, 8862838, 9140871, 9049946, 9007346, 8934280; 4) MODEL/ITEM NUMBER BHOP48P: UDI/DI 00191072234544, Kit Lot Numbers: 9268782, 9345847; 5) MODEL/ITEM NUMBER BHPH18F: UDI/DI 00191072224651, Kit Lot Numbers: 8993526, 9098058, 8899297; 6) MODEL/ITEM NUMBER BHPH18G: UDI/DI 00191072234551, Kit Lot Numbers: 9238544; 7) MODEL/ITEM NUMBER HGCB98F: UDI/DI 00191072205285, Kit Lot Numbers: 42-7813711; 8) MODEL/ITEM NUMBER HGCV05K: UDI/DI 00191072212474, Kit Lot Numbers: 42-8097611, 42-8021411, 42-7870011, 42-7831911, 42-8093211; 9) MODEL/ITEM NUMBER HGOH99H: UDI/DI 00191072235336, Kit Lot Numbers: 42-8119511, 42-8044311, 42-7874411; 10) MODEL/ITEM NUMBER MHCV10AM: UDI/DI 00191072235619. Kit Lot Numbers: 42-7848211; 11) MODEL/ITEM NUMBER MTVS73D: UDI/DI 00191072237583, Kit Lot Numbers: 12-7397911, 12-7335111, 12-7072111, 12-7142511, 12-7224911; 12) MODEL/ITEM NUMBER RCAV40C: UDI/DI 00191072235381, Kit Lot Numbers: 42-8053511, 42-8151011, 42-7978811, 42-7853911; 13) MODEL/ITEM NUMBER RCOH61G: UDI/DI 00191072229823, Kit Lot Numbers: 42-7803611, 42-7941711, 42-7997711, 42-8075711; 14) MODEL/ITEM NUMBER TNCA08T: UDI/DI 00191072235534, Kit Lot Numbers: 42-7827011, 42-8158811; 15) MODEL/ITEM NUMBER TNCB10AM: UDI/DI 00191072232991, Kit Lot Numbers: 42-7864811, 42-7971311, 42-8065311; 16) MODEL/ITEM NUMBER UDAV16AD: UDI/DI 00191072216229, Kit Lot Numbers: 42-7919811; 17) MODEL/ITEM NUMBER UDCP24AF: UDI/DI 00191072235305, Kit Lot numbers: 42-8010311, 42-8109811; 18) MODEL/ITEM NUMBER UDFP36AH: UDI/DI 00191072235329, Kit Lot Numbers: 42-7835011, 42-7902811, 42-8014011, 42-8091211; 19) MODEL/ITEM NUMBER UICD62AN: UDI/DI 00191072200495, Kit Lot Numbers: 42-7874211, 42-7934511, 42-7999011, 42-8072211, 42-8132211; 20) MODEL/ITEM NUMBER UICS88S: UDI/DI 00191072235428, Kit Lot Numbers: 42-7821511, 42-7913211, 42-7979011, 42-8032611, 42-8106011; 21) MODEL/ITEM NUMBER UIPD03Q: UDI/DI 00191072235435, Kit Lot Numbers: 42-8083011, 42-8154511; 22) MODEL/ITEM NUMBER UITC53AL: UDI/DI 00191072235572, Kit Lot Numbers: 42-7887011, 42-7993911, 42-8071411; 23) MODEL/ITEM NUMBER UIVA75J: UDI/DI 00191072235602, Kit Lot Numbers: 42-7994011, 42-8056011, 42-8114011, 42-7827411, 42-7916411; 24) MODEL/ITEM NUMBER UMCA14E: UDI/DI 00191072222510, Kit Lot Numbers: 334022, 9238536; 25) MODEL/ITEM NUMBER UMOH42E: UDI/DI 00191072222534, Kit Lot Numbers: 8860283; 26) MODEL/ITEM NUMBER UMOH42F: UDI/DI 00191072224712, Kit Lot Numbers: 9125072, 9044687, 8977422, 8925203, 9167965; 27) MODEL/ITEM NUMBER UMOH42G: UDI/DI 00191072234896, Kit Lot Numbers: 9202772, 9334223.
UPC codes
00191072235169, 00191072235183, 00191072221490, 00191072234544, 00191072224651, 00191072234551, 00191072205285, 00191072212474, 00191072235336, 00191072237583, 00191072235381, 00191072229823, 00191072235534, 00191072232991, 00191072216229, 00191072235305, 00191072235329, 00191072200495, 00191072235428, 00191072235435

Products covered by this recall

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O; 4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P; 5) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18F; 6) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18G; 7) CABG ACCESSORY PACK, MODEL/ITEM NUMBER HGCB98F; 8) CV SET UP PACK, MODEL/ITEM NUMBER HGCV05K; 9) OPEN HEART PACK B - COMPONENTS, MODEL/ITEM NUMBER HGOH99H; 10) STRADLE TABLE PACK - 301659, MODEL/ITEM NUMBER MHCV10AM; 11) MINOR VASCULAR PACK, MODEL/ITEM NUMBER MTVS73D; 12) AV GRAFT RCH 0246952, MODEL/ITEM NUMBER RCAV40C; 13) OPEN HEART PART 1 RCH 0247159, MODEL/ITEM NUMBER RCOH61G; 14) CARDIO 612968, MODEL/ITEM NUMBER TNCA08T; 15) CV B PACK, MODEL/ITEM NUMBER TNCB10AM; 16) A-V FISTULA - 206042, MODEL/ITEM NUMBER UDAV16AD; 17) CAROTID PACK - 206045, MODEL/ITEM NUMBER UDCP24AF; 18) FEM POP PACK - 206052, MODEL/ITEM NUMBER UDFP36AH; 19) CARDIOVASCULAR SUPPLY (PS 907285), MODEL/ITEM NUMBER UICD62AN; 20) SFCH PEDS CARDIAC SUPPLY PACK (PS131653), MODEL/ITEM NUMBER UICS88S; 21) SFCH ECMO PACK (PS 107116), MODEL/ITEM NUMBER UIPD03Q; 22) THORACIC SETUP (PS 035700), MODEL/ITEM NUMBER UITC53AL; 23) VASCULAR PACK, MODEL/ITEM NUMBER UIVA75J; 24) CABG ACCESSORY PACK 175619, MODEL/ITEM NUMBER UMCA14E; 25) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42E; 26) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42F; 27) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42G.

Check your product

The notice names 60 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.

  • 00191072235169
  • 00191072235183
  • 00191072221490
  • 00191072234544
  • 00191072224651
  • 00191072234551
  • 00191072205285
  • 00191072212474
  • 00191072235336
  • 00191072237583
  • 00191072235381
  • 00191072229823
  • 00191072235534
  • 00191072232991
  • 00191072216229
  • 00191072235305
  • 00191072235329
  • 00191072200495
  • 00191072235428
  • 00191072235435

Lot or batch code

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

  • 42-7844511
  • 42-8133811
  • 42-8037211
  • 42-7952411
  • 42-7882011
  • 42-8025011
  • 42-8108511
  • 42-7928511
  • 9207467
  • 8862838
  • 9140871
  • 9049946
  • 9007346
  • 8934280
  • 9268782
  • 9345847
  • 8993526
  • 9098058
  • 8899297
  • 9238544

Model or item number

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

  • ANCV78BC
  • ANVA82AB
  • BHOP48O
  • BHOP48P
  • BHPH18F
  • BHPH18G
  • HGCB98F
  • HGCV05K
  • HGOH99H
  • MHCV10AM
  • MTVS73D
  • RCAV40C
  • 1 RCH 0247159
  • MODEL
  • TNCA08T
  • TNCB10AM
  • UDAV16AD
  • UDCP24AF
  • UDFP36AH
  • UICD62AN

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 Sterility

American Contract Systems Inc — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  3. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  4. Report any infection or reaction you think the product caused to FDA MedWatch.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: American Contract Systems Inc — 85 Shaffer Park Dr, Tiffin, OH, 44883-9290

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?

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met. During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00191072235169, 00191072235183, 00191072221490; lot code 42-7844511, 42-8133811, 42-8037211; model number ANCV78BC, ANVA82AB, BHOP48O. 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 affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Which states were affected?

The notice lists Illinois, Louisiana.

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