AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item
Summary
The FDA issued a Class II for AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A by American Contract Systems Inc. Reason: During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some comp.
Details
Source
Device Recall
External ID
Z-2467-2025
Action Date
2025-09-03
Status
Ongoing
Category
device
Product 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.
Lot/Code Info: 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.
Quantity Affected: 6617 units
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.
Distribution
US distribution to states of: IL and LA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-14
Company
Tiffin, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
American Contract Systems Inc has 188 FDA actions in our database, including 188 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Contract Systems Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Contract Systems Inc have FDA actions?
American Contract Systems Inc has 188 FDA actions in our database, including 188 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2467-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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