| | 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-2464-2025 |
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| Recall Event ID |
97358 |
| Product Classification |
Cardiovascular procedure kit - Product Code OEZ
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| Product | AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:
1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC;
2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB;
3) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48O;
4) OFF PUMP CABG PACK - 170316, MODEL/ITEM NUMBER BHOP48P;
5) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18F;
6) PEDIATRIC OPEN HEART PACK - 170212, MODEL/ITEM NUMBER BHPH18G;
7) CABG ACCESSORY PACK, MODEL/ITEM NUMBER HGCB98F;
8) CV SET UP PACK, MODEL/ITEM NUMBER HGCV05K;
9) OPEN HEART PACK B - COMPONENTS, MODEL/ITEM NUMBER HGOH99H;
10) STRADLE TABLE PACK - 301659, MODEL/ITEM NUMBER MHCV10AM;
11) MINOR VASCULAR PACK, MODEL/ITEM NUMBER MTVS73D;
12) AV GRAFT RCH 0246952, MODEL/ITEM NUMBER RCAV40C;
13) OPEN HEART PART 1 RCH 0247159, MODEL/ITEM NUMBER RCOH61G;
14) CARDIO 612968, MODEL/ITEM NUMBER TNCA08T;
15) CV B PACK, MODEL/ITEM NUMBER TNCB10AM;
16) A-V FISTULA - 206042, MODEL/ITEM NUMBER UDAV16AD;
17) CAROTID PACK - 206045, MODEL/ITEM NUMBER UDCP24AF;
18) FEM POP PACK - 206052, MODEL/ITEM NUMBER UDFP36AH;
19) CARDIOVASCULAR SUPPLY (PS 907285), MODEL/ITEM NUMBER UICD62AN;
20) SFCH PEDS CARDIAC SUPPLY PACK (PS131653), MODEL/ITEM NUMBER UICS88S;
21) SFCH ECMO PACK (PS 107116), MODEL/ITEM NUMBER UIPD03Q;
22) THORACIC SETUP (PS 035700), MODEL/ITEM NUMBER UITC53AL;
23) VASCULAR PACK, MODEL/ITEM NUMBER UIVA75J;
24) CABG ACCESSORY PACK 175619, MODEL/ITEM NUMBER UMCA14E;
25) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42E;
26) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42F;
27) OPEN HEART ACCESS PACK 175628, MODEL/ITEM NUMBER UMOH42G. |
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| Code Information |
1) MODEL/ITEM NUMBER ANCV78BC: UDI/DI 00191072235169, Kit Lot Numbers: 42-7844511, 42-8133811, 42-8037211, 42-7952411, 42-7882011;
2) MODEL/ITEM NUMBER ANVA82AB: UDI/DI 00191072235183, Kit Lot Numbers: 42-8025011, 42-8108511, 42-7928511;
3) MODEL/ITEM NUMBER BHOP48O: UDI/DI 00191072221490, Kit Lot Numbers: 9207467, 8862838, 9140871, 9049946, 9007346, 8934280;
4) MODEL/ITEM NUMBER BHOP48P: UDI/DI 00191072234544, Kit Lot Numbers: 9268782, 9345847;
5) MODEL/ITEM NUMBER BHPH18F: UDI/DI 00191072224651, Kit Lot Numbers: 8993526, 9098058, 8899297;
6) MODEL/ITEM NUMBER BHPH18G: UDI/DI 00191072234551, Kit Lot Numbers: 9238544;
7) MODEL/ITEM NUMBER HGCB98F: UDI/DI 00191072205285, Kit Lot Numbers: 42-7813711;
8) MODEL/ITEM NUMBER HGCV05K: UDI/DI 00191072212474, Kit Lot Numbers: 42-8097611, 42-8021411, 42-7870011, 42-7831911, 42-8093211;
9) MODEL/ITEM NUMBER HGOH99H: UDI/DI 00191072235336, Kit Lot Numbers: 42-8119511, 42-8044311, 42-7874411;
10) MODEL/ITEM NUMBER MHCV10AM: UDI/DI 00191072235619. Kit Lot Numbers: 42-7848211;
11) MODEL/ITEM NUMBER MTVS73D: UDI/DI 00191072237583, Kit Lot Numbers: 12-7397911, 12-7335111, 12-7072111, 12-7142511, 12-7224911;
12) MODEL/ITEM NUMBER RCAV40C: UDI/DI 00191072235381, Kit Lot Numbers: 42-8053511, 42-8151011, 42-7978811, 42-7853911;
13) MODEL/ITEM NUMBER RCOH61G: UDI/DI 00191072229823, Kit Lot Numbers: 42-7803611, 42-7941711, 42-7997711, 42-8075711;
14) MODEL/ITEM NUMBER TNCA08T: UDI/DI 00191072235534, Kit Lot Numbers: 42-7827011, 42-8158811;
15) MODEL/ITEM NUMBER TNCB10AM: UDI/DI 00191072232991, Kit Lot Numbers: 42-7864811, 42-7971311, 42-8065311;
16) MODEL/ITEM NUMBER UDAV16AD: UDI/DI 00191072216229, Kit Lot Numbers: 42-7919811;
17) MODEL/ITEM NUMBER UDCP24AF: UDI/DI 00191072235305, Kit Lot numbers: 42-8010311, 42-8109811;
18) MODEL/ITEM NUMBER UDFP36AH: UDI/DI 00191072235329, Kit Lot Numbers: 42-7835011, 42-7902811, 42-8014011, 42-8091211;
19) MODEL/ITEM NUMBER UICD62AN: UDI/DI 00191072200495, Kit Lot Numbers: 42-7874211, 42-7934511, 42-7999011, 42-8072211, 42-8132211;
20) MODEL/ITEM NUMBER UICS88S: UDI/DI 00191072235428, Kit Lot Numbers: 42-7821511, 42-7913211, 42-7979011, 42-8032611, 42-8106011;
21) MODEL/ITEM NUMBER UIPD03Q: UDI/DI 00191072235435, Kit Lot Numbers: 42-8083011, 42-8154511;
22) MODEL/ITEM NUMBER UITC53AL: UDI/DI 00191072235572, Kit Lot Numbers: 42-7887011, 42-7993911, 42-8071411;
23) MODEL/ITEM NUMBER UIVA75J: UDI/DI 00191072235602, Kit Lot Numbers: 42-7994011, 42-8056011, 42-8114011, 42-7827411, 42-7916411;
24) MODEL/ITEM NUMBER UMCA14E: UDI/DI 00191072222510, Kit Lot Numbers: 334022, 9238536;
25) MODEL/ITEM NUMBER UMOH42E: UDI/DI 00191072222534, Kit Lot Numbers: 8860283;
26) MODEL/ITEM NUMBER UMOH42F: UDI/DI 00191072224712, Kit Lot Numbers: 9125072, 9044687, 8977422, 8925203, 9167965;
27) MODEL/ITEM NUMBER UMOH42G: UDI/DI 00191072234896, Kit Lot Numbers: 9202772, 9334223.
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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 | 31506 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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