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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- American Contract Systems Inc
- Reason for Recall:
- 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 I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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.
Distribution:
Distributed in: US, IL, LA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2467-2025
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American Contract Systems
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American Contract Systems
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.