Class II FDA device recall · Z-2467-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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 Number HSCY13M; 5) PICC DRESSING CHANGE KIT, Model/Item Number HSDR10K; 6) MIDLINE CHANGE KIT, Model/Item Number HSMD20H; 7) SHOULDER ARTHOSCOPY PACK, Model/Item Number PDSA12D; 8) PDA LF SJW, Model/Item Number SWPD12K; 9) AAA PACK - 206038, Model/Item Number UDAA63AH; 10) BASIC CAB PACK - 206043, Model/Item Number UDBC35AF; 11) BASIC HEART PACK - 206044, Model/Item Number UDBH37AX; 12) FREE FLAP DRAPE PACK (PS 907864), Model/Item Number UIFF72AD; 13) PROCUREMENT PACK, Model/Item Number UIPC89D; 14) THYROID PACK (PS 096552), Model/Item Number UITR45W; 15) TRAUMA PACK 175634, Model/Item Number UMTR17B; 16) TRAUMA PACK 175634, Model/Item Number UMTR17C.

Why it was 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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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, Kit Lot Numbers:  70-053496;  8)  Model/Item Number SWPD12K:  UDI/DI 00191072228512, Kit Lot Numbers:  5437920, 5436824, 5436860, 5437058, 5437174, 5437197, 5437211, 5437326, 5437390, 5437696, 5437720, 5437752, 5437800, 5437859, 5438008, 5438056, 5438066, 5438331, 5438336, 5438446, 5438033 , 5438535;  9)  Model/Item Number UDAA63AH:  UDI/DI 00191072235275, Kit Lot Numbers:  42-8052111, 42-8104211;  10)  Model/Item Number UDBC35AF:  UDI/DI 00191072103420, Kit Lot Numbers:  42-7867111, 42-7940911, 42-7981511;  11)  Model/Item Number UDBH37AX:  UDI/DI 00191072012098, Kit Lot Numbers:  42-7867811, 42-7947511, 42-8007611, 42-8032411;  12)  Model/Item Number UIFF72AD:  UDI/DI 00191072235541, Kit Lot Numbers:  42-7849111, 42-7947711, 42-8024111, 42-8095211;  13)  Model/Item Number UIPC89D:  UDI/DI 00191072205742, Kit Lot Numbers:  42-8024311, 42-8113911;  14)  Model/Item Number UITR45W:  UDI/DI 00191072235589, Kit Lot Numbers:  42-7875311, 42-7980811, 42-8067111;  15)  Model/Item Number UMTR17B:  UDI/DI 00191072222596, Kit Lot Numbers:  9124674, 8925186, 9003138, 9051991 16)  Model/Item Number UMTR17C:  UDI/DI 00191072233806, Kit Lot Numbers:  " 9202780, 9292532.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

US distribution to states of: IL and LA

Recall record

Recalling firm: American Contract Systems Inc
Product type: Devices
Recall number: Z-2467-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: E-Mail
Origin: Tiffin, OH
Recall initiated: 2025-07-14

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2467-2025 · Source: openFDA enforcement.