CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report
Medical Procedure kits and trays labeled as: Heart Pack recalled
American Contract Systems is recalling Medical Procedure kits and trays labeled as: Heart Pack - 205947, distributed in Illinois, Louisiana. The recall was initiated on 14 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2464-2025
- FDA event ID
- 97358
- Recalling firm
- American Contract Systems, Tiffin, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Jul 2025
- FDA classified
- 28 Aug 2025
- Reported
- 3 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 14 Jul 2025 | Recall initiated by company | |
| 28 Aug 2025 | Classified by FDA | +45 days |
| 3 Sep 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US distribution to states of: IL and LA
Questions about this recall
Why was it 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.
Which lots are affected?
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.
Where was it sold?
US distribution to states of: IL and LA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 97358This product is part of a recall event; the main page for the event is Medical Procedure kits and trays labeled as: Anterior Hip Pack recalled.
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