| | Class 2 Device Recall AMERICAN CONTRACT SYSTEMS |  |
| Date Initiated by Firm | July 14, 2025 |
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| Date Posted | August 28, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2467-2025 |
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| Recall Event ID |
97358 |
| Product Classification |
General surgery tray - Product Code LRO
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| 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. |
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| 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.
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| FEI Number |
3008492337
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Recalling Firm/
Manufacturer |
American Contract Systems Inc
85 Shaffer Park Dr
Tiffin OH 44883-9290
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| For Additional Information Contact | Marlene Jones
470-280-4277 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Owens & Minor issued an "URGENT: MEDICAL DEVICE CORRECTION" notice to its consignees on 07/15/2025 via email. The notice explained the problem, potential risk to health, and requested the following:
ACTIONS TO TAKE:
" Discontinue use of all affected components.
" Add warning labels to affected procedure trays to ensure the components are discarded. A labeling template is enclosed for printing labels which can be affixed on all affected kits in inventory. This label should be applied to each affected procedure tray and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling.
o Customers (end-users): If you receive a product from a distributor, please contact the distributor or your sales representative with any questions you may have.
o Distributors: If any of the affected procedure trays identified above were further distributed, please ensure all end-users are appropriately notified of this product correction and maintain records of effectiveness for your consignees.
" Complete the attached Recall Response Form and return as soon as possible to GM-OMRA_RECALLS@owens-minor.com.
Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com.
If you have any questions, contact the Manager, Regulatory Affairs at 470-280-4277 or email to: GM-OMRA_RECALLS@owens-minor.com. |
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| Quantity in Commerce | 6617 units |
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| Distribution | US distribution to states of: IL and LA |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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