High FDA (Devices)·Z-2464-2025·Announced 2025-09-03

Heart and vascular packs recalled because sterilization rationale was not justified

American Contract Systems heart, vascular and off-pump CABG packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 31,506 units are affected.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; unconfirmed sterility on a cardiac surgery pack is a potential harm and no injuries are reported.

Plain-English summary

American Contract Systems medical procedure kits and trays labelled as Heart Pack (205947), model/item number ANCV78BC; Vascular Pack (232024), model/item number ANVA82AB; and Off Pump CABG Pack (170316), model/item number BHOP48O, are being recalled, along with further kits listed in the notice. Affected kit lot numbers are listed per item, with UDI/DI 00191072235169 for the heart pack. The recall covers 31,506 units distributed in Illinois and Louisiana.

During an internal investigation, American Contract Systems determined that the rationale for sterilization of certain components was not justified and that some components are not fit for further sterilization according to its procedures. As a result, the firm is unable to confirm that product sterilization assurance requirements were met. The FDA classified the action as Class II.

Hospitals and surgical centres holding these lot numbers should quarantine affected stock and follow the manufacturer's instructions for return or replacement.

The recalled product

Product: 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, M
Manufacturer: American Contract Systems Inc
Category: Medical Device — Procedure Kits
Hazard: sterility-assurance
surgical-kit
class-ii
Affected units: 31,506

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 9 recalled by American Contract Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Same manufacturer · American Contract Systems Inc

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Same hazard · sterility assurance