American Contract Systems recall
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024…
Why was American Contract Systems 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models 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.
- Product
- AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024…
- Recalling firm
- American Contract Systems Inc
- Quantity
- 31506 units
- Distribution
- US distribution to states of: IL and LA
- Recall date
- September 3, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)