Recall archive / FDA device enforcement
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item N... — FDA record Z-2467-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 14, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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 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.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- American Contract Systems Inc
- Quantity
- 6617 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2467-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to states of: IL and LA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 3, 2025
- Recall initiation date
- Jul 14, 2025
- Center classification date
- Aug 28, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.