High FDA (Devices)·Z-2467-2025·Announced 2025-09-03

Perfusion and laparoscopy packs recalled over unjustified sterilization of certain components

American Contract Systems supplement, kidney perfusion and lapchol/appy packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 6,617 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 surgical procedure pack is a potential harm and no injuries are reported.

Plain-English summary

American Contract Systems medical procedure kits and trays labelled as A-C Supplement Pack (205946), model/item number ANCV67X; Kidney Perfusion Pack (208439), model/item number ANKP15AD; and LapChol/Appy Pack, model/item number FYLA38G, are being recalled. Affected kit lot numbers are listed in the recall notice, with UDI/DI 00191072203021 for the supplement pack. The recall covers 6,617 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) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item N
Manufacturer: American Contract Systems Inc
Category: Medical Device — Procedure Kits
Hazard: sterility-assurance
surgical-kit
class-ii
Affected units: 6,617

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 ANCV67X: UDI/DI 00191072203021
Kit Lot Numbers: 42-7789611
42-8074911
42-7925811
42-8005111
2) Model/Item Number ANKP15AD: UDI/DI 00191072235176
Kit Lot Numbers: 42-7916611
42-8047711
3) Model/Item Number FYLA38G: UDI/DI 00191072003706
Kit Lot Numbers: 42-7905711
42-8134111
4) Model/Item Number HSCY13M: UDI/DI 00191072005571
Kit Lot Numbers: 42-8125311
42-7959411
5) Model/Item Number HSDR10K: UDI/DI 00191072005588
Kit Lot Numbers: 42-7984111
42-7883711
6) Model/Item Number HSMD20H: UDI/DI 00191072237262
Kit Lot Numbers: 42-7937911
7) Model/Item Number PDSA12D: UDI/DI 00191072137111

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