American Contract Systems, Inc.: Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number AGOH98Q; f) OPEN HEART ACCESSORY, kit number AGOH98R; g) OPEN HEART ACCESSORY, kit number AGOH98S; h) PERIPHERAL VASCULAR, kit number AGPV28O; i) PERIPHERAL VASCULAR, kit number AGPV28P; j) MINOR VASCULAR, kit number AHMV26J; k) MINOR VASCULAR, kit number AHMV26K; l) HEART PACK - 205947, kit number ANCV78AX; m) HEART PACK - 205947 , kit number ANCV78AX1; n) HEART PACK - 205947 Post Open-Heart, kit number ANHK74N; o) OPEN HEART EAST PACK, kit number BHOH43; p) 74OFF PUMP CABG PACK, kit number BHOP48; q) PACEMAKER PACK, kit number BHPM60; r) FORBES EP LAB DEVICE IMPLANT PK, kit number FBDI42K; s) T AND A PACK AGH ASC, kit number FBDI42L; t) T AND A PACK AGH ASC, kit number FBDI42M; u) THORACOSCOPY PACK, kit number FBTO60G; v) OPEN HEART ACCESSORY PACK, kit number JROH00O; w) OPEN HEART ACCESSORY PACK, kit number JROH98O; x) ADULT OPEN HEART PACK, kit number LLOH52; y) ADULT OPEN HEART PACK, kit number LLOP25; z) PACEMAKER PACK, kit number LLPP14; aa) HEART PACK, kit number LMCB06AD; bb) CARDIAC HEART BUNDLE NS, kit number LMCH99O; cc) OPEN HEAART PACK, kit number LMOH50AD; dd) OPEN HEAART PACK, kit number LMOH50AD-01; ee) OPEN HEAART PACK, kit number LMOH50AD-02; ff) OPEN HEAART PACK, kit number LMOH50AE; gg) CV PACK, kit number MMCV98V; hh) CV PACK, kit number MMCV98V-03; ii) CV PACK, kit number MMCV98V-04; jj) KIT OPEN HEART ADULT, kit number MMOH64J; kk) PACEMAKER PACK, kit number MMPM27E; ll) KIT, THORACOTOMY UNIVERSAL, kit number MMTR12F; mm) ANT CERV FUSION PACK, kit number NCAC96; nn) OPEN HEART- ACCESSOR, kit number NCOH11; oo) VASCULAR SAH, kit number SAVA91G; pp) VASCULAR SAH, kit number SAVA91H; qq) VASCULAR SAH, kit number SAVA91I; rr) VASCULAR SAH, kit number SAVA91J; ss) OPEN HEART BRINGBACK SJH, kit number SJOH17I; tt) OPEN HEART CV SJH, kit number SJOH28L; uu) PEDIATRIC HEART SJH, kit number SJPH34K; vv) VASC OPEN CVOR SJH, kit number SJVO56A; ww) VASC OPEN CVOR SJH, kit number SJVO56B; xx) MAJOR CV TRAY, kit number SVMJ20L; yy) MAJOR CV TRAY, kit number SVMJ20M; zz) MINOR CV TRAY, kit number SVMN60J; aaa) OPEN HEART COMPONENT PACK, kit number SVOH38Q; bbb) CV B PACK, kit number TNCB10AK; ccc) CARDIOVASCULAR SUPPLY (PS 907285), kit number UICD62AM

Recall number

Z-0818-2024

Recalling firm

American Contract Systems, Inc.

Product

Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number AGOH98Q; f) OPEN HEART ACCESSORY, kit number AGOH98R; g) OPEN HEART ACCESSORY, kit number AGOH98S; h) PERIPHERAL VASCULAR, kit number AGPV28O; i) PERIPHERAL VASCULAR, kit number AGPV28P; j) MINOR VASCULAR, kit number AHMV26J; k) MINOR VASCULAR, kit number AHMV26K; l) HEART PACK - 205947, kit number ANCV78AX; m) HEART PACK - 205947 , kit number ANCV78AX1; n) HEART PACK - 205947 Post Open-Heart, kit number ANHK74N; o) OPEN HEART EAST PACK, kit number BHOH43; p) 74OFF PUMP CABG PACK, kit number BHOP48; q) PACEMAKER PACK, kit number BHPM60; r) FORBES EP LAB DEVICE IMPLANT PK, kit number FBDI42K; s) T AND A PACK AGH ASC, kit number FBDI42L; t) T AND A PACK AGH ASC, kit number FBDI42M; u) THORACOSCOPY PACK, kit number FBTO60G; v) OPEN HEART ACCESSORY PACK, kit number JROH00O; w) OPEN HEART ACCESSORY PACK, kit number JROH98O; x) ADULT OPEN HEART PACK, kit number LLOH52; y) ADULT OPEN HEART PACK, kit number LLOP25; z) PACEMAKER PACK, kit number LLPP14; aa) HEART PACK, kit number LMCB06AD; bb) CARDIAC HEART BUNDLE NS, kit number LMCH99O; cc) OPEN HEAART PACK, kit number LMOH50AD; dd) OPEN HEAART PACK, kit number LMOH50AD-01; ee) OPEN HEAART PACK, kit number LMOH50AD-02; ff) OPEN HEAART PACK, kit number LMOH50AE; gg) CV PACK, kit number MMCV98V; hh) CV PACK, kit number MMCV98V-03; ii) CV PACK, kit number MMCV98V-04; jj) KIT OPEN HEART ADULT, kit number MMOH64J; kk) PACEMAKER PACK, kit number MMPM27E; ll) KIT, THORACOTOMY UNIVERSAL, kit number MMTR12F; mm) ANT CERV FUSION PACK, kit number NCAC96; nn) OPEN HEART- ACCESSOR, kit number NCOH11; oo) VASCULAR SAH, kit number SAVA91G; pp) VASCULAR SAH, kit number SAVA91H; qq) VASCULAR SAH, kit number SAVA91I; rr) VASCULAR SAH, kit number SAVA91J; ss) OPEN HEART BRINGBACK SJH, kit number SJOH17I; tt) OPEN HEART CV SJH, kit number SJOH28L; uu) PEDIATRIC HEART SJH, kit number SJPH34K; vv) VASC OPEN CVOR SJH, kit number SJVO56A; ww) VASC OPEN CVOR SJH, kit number SJVO56B; xx) MAJOR CV TRAY, kit number SVMJ20L; yy) MAJOR CV TRAY, kit number SVMJ20M; zz) MINOR CV TRAY, kit number SVMN60J; aaa) OPEN HEART COMPONENT PACK, kit number SVOH38Q; bbb) CV B PACK, kit number TNCB10AK; ccc) CARDIOVASCULAR SUPPLY (PS 907285), kit number UICD62AM

Status

Open, Classified

Initiated

2023-11-29

Posted

2024-01-26

Terminated

not on file

Reason

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Root cause

Process control

Action

Owens & Minor issued an URGENT: MEDICAL DEVICE CORRECTION notice to it consignees on 11/29/2023 via email. Then notice explained the problem, risk to health, and requested the following actions be taken: If you received any of the batches/lots identified, please segregate and quarantine all affected product. Add warning labels to all kits/cases impacted: A labeling template is enclosed for printing warning labels which should be affixed to all affected product in inventory. This label should be affixed to each affected kit and 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. " Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. " Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified of this field correction and maintain records of effectiveness. Report any quality problems or adverse events associated with the products listed in this notification to complaints@owens-minor.com.

Quantity

12291 units

Distribution

US Nationwide distribution.

Lot, serial or model codes

a) AGBI64J, UDI/DI 0019107247578, Lot numbers: 956231, exp. 2/13/2024; 674221, exp. 11/22/2023; 699221, exp. 10/28/2023; 727221, exp. 9/30/2023; 731221, exp. 9/26/2023; 769221, exp. 8/19/2023; 876221, exp. 5/4/2023; b) AGDI40J, UDI/DI 00191072154668, Lot numbers: 956231, exp. 7/31/2023; 647221, exp. 7/31/2023; 708221, exp. 7/31/2023; 750221, exp. 7/31/2023; c) AGDI40K, UDI/DI 00191072188168, Lot numbers: 910231, exp. 3/31/2024; 904231, exp. 4/6/2024; d) AGMV26O, UDI/DI 00191072179777, Lot numbers: 900231, exp. 2/23/2024; 912231, exp. 2/23/2024; 949231, exp. 2/20/2023; 982231, exp. 1/18/2024; 666221, exp. 11/30/2023; 713221, exp. 10/14/2023; 763221, exp. 8/25/2023; 822221, exp. 6/27/2023; e) AGOH98Q, UDI/DI 00191072159419, Lot numbers: 846221, exp. 6/3/2023; f) AGOH98R, UDI/DI 00191072169754, Lot numbers: 742221, exp. 9/15/2023; 772221, exp. 8/16/2023; 794221, exp. 7/25/2023; g) AGOH98S, UDI/DI 00191072179784, Lot numbers: 921231, exp. 7/31/2023; 636221, exp. 10/10/2023; 685221, exp. 11/11/2023; 707221, exp. 7/31/2023; 729221, exp. 7/31/2023; h) AGPV28O, UDI/D I00191072137210, Lot numbers: 847221, exp. 6/2/2023; i) AGPV28P, UDI/DI 00191072179791, Lot numbers: 771221, exp. 8/17/2023; 961231, exp. 2/8/2024; 696221, exp. 10/31/2023; j) AHMV26J, UDI/DI 00191072137586, Lot numbers: 735221, exp. 9/22/2023; 790221, exp. 7/29/2023; 839221, exp. 6/10/2023; k) AHMV26K, UDI/DI 00191072179807, Lot numbers: 896231, exp. 4/14/2024; 977231, exp. 1/23/2024; 953231, exp. 2/16/2024; 969231, exp. 1/31/2024; 686221, exp. 11/10/2023; 721221, exp. 10/6/2023; l) ANCV78AX, UDI/DI 00191072182692, Lot numbers: 706221, exp. 10/21/2023; m) ANCV78AX1, UDI/DI 00191072182692, Lot numbers: 647221, exp. 12/19/2023; n) ANHK74N, UDI/DI 00191072191472, Lot numbers: 706221, exp. 10/21/2023; o) BHOH43, UDI/DI 00191072160690, Lot numbers: 960231, exp. 2/9/2023; 668221, exp. 11/28/2023; 734221, exp. 9/23/2023; 773221, exp. 8/15/2023; 828221, exp. 6/21/2023; 876221, exp. 5/4/2023; 902221, exp. 4/8/2023; p) BHOP48, UDI/DI 00191072164131, Lot numbers: 921231, exp. 3/20/2024; 948231, exp. 2/21/2024; 984231, exp. 1/16/2024; 783221, exp. 8/5/2023; 688221, exp. 1/8/2023; 736221, exp. 9/12/2023; 833221, exp. 6/16/2023; 867221, exp. 5/13/2023; 903221, exp. 4/7/2023; q) BHPM60, UDI/DI 00191072160799, Lot numbers: 928231, exp. 3/13/2024; 968231, exp. 2/1/2024; 651221, exp. 12/15/2023; 702221, exp. 10/25/2023; 762221, exp. 8/26/2023; 836221, exp. 6/13/2023; 883221, exp. 4/27/2023; r) FBDI42K, UDI/DI 00191072169761, Lot numbers: 976231, exp. 7/31/2023; 644221, exp. 7/31/2023; 678221, exp. 7/31/2023; 716221, exp. 7/31/2023; 743221, exp. 7/31/2023; 758221, exp. 7/31/2023; 828221, exp. 6/21/2023; 846221, exp. 6/3/2023; s) FBDI42L, UDI/DI 00191072189905, Lot numbers: 920231, exp. 7/31/2023; 942231, exp. 7/31/2023; t) FBDI42M, UDI/DI 00191072192066, Lot numbers: 899231, exp. 4/11/2024; u) FBTO60G, UDI/DI 00191072164219, Lot numbers: 654221, exp. 12/12/2023; 689221, exp. 11/7/2023; v) JROH00O, UDI/DI 00191072179814, Lot numbers: 906231, exp. 4/4/2024; 932231, exp. 3/9/2024; 935231, exp. 8/21/2023; 968231, exp. 2/1/2024; 988231, exp. 12/9/2023; w) JROH98O, UDI/DI 00191072179821, Lot numbers: 900231, exp. 4/10/2024; 657221, exp. 11/18/2023; 686221, exp. 10/14/2023; 713221, exp. 9/14/2023; x) LLOH52, UDI/DI 00191072169785, Lot numbers: 729221, exp. 9/28/2023; 722221, exp. 10/5/2023; 668221, exp. 11/28/2023; 980231, exp. 1/20/2024; 903231, exp. 4/7/2024; y) LLOP25, UDI/DI 00191072167347, Lot numbers: 766221, exp. 8/22/2023; 729221, exp. 9/28/2023; z) LLPP14, UDI/DI 00191072167354, Lot numbers: 741221, exp. 9/16/2023; 695221, exp. 11/1/2023; 639221, exp. 12/27/2023; 940231, exp. 3/1/2024; aa) LMCB06AD, UDI/DI none, Lot numbers: 721221, exp. 10/6/2023; 675221, exp. 11/21/2023; 927231, exp. 3/14/2024; 890231, exp. 4/20/2024; bb) LMCH99O, UDI/DI none, Lot numbers: 762221, exp. 8/26/2023; 715221, exp. 10/12/2023; 674221, exp. 11/22/2023; 872231, exp. 5/8/2024; cc) LMOH50AD, UDI/DI 00191072165534, Lot numbers: 847221, exp. 6/2/2023; 833221, exp. 6/16/2023; 807221, exp. 7/12/2023; 751221, exp. 8/27/2023; dd) LMOH50AD-01, UDI/DI 0019107216553 , Lot numbers: 878221, exp. 5/2/2023; 765221, exp. 8/23/2023; ee) LMOH50AD-02, UDI/DI 00191072165534, Lot numbers: 731221, exp. 9/26/2023; 682221, exp. 11/14/2023; ff) LMOH50AE, UDI/DI 00191072184443, Lot numbers: 973231, exp. 1/27/2024; gg) MMCV98V, UDI/DI 00191072155481, Lot numbers: 867221, exp. 5/13/2023; 828221, exp. 6/21/2023; 949231, exp. 2/20/2024; hh) MMCV98V-03, UDI/DI 00191072155481, Lot numbers: 783221, exp. 8/5/2023; ii) MMCV98V-04, UDI/DI 00191072155481, Lot numbers: 681221, exp. 11/15/2023; jj) MMOH64J, UDI/DI none, Lot numbers: 933231, exp. 3/8/2024; 871231, exp. 5/9/2024; kk) MMPM27E, UDI/DI none, Lot numbers: 935231, exp. 3/6/2024; ll) MMTR12F, UDI/DI none, Lot numbers: 889231, exp. 4/21/2024; mm) NCAC96, UDI/DI 00191072016829, Lot numbers: 963231, exp. 8/18/2023; 996231, exp. 6/2/2023; 715221, exp. 6/2/2023; 811221, exp. 6/2/2023; 863221, exp. 5/17/2023; nn) NCOH11, UDI/DI 00191072160867, Lot numbers: 956231, exp. 2/13/2024; 674221, exp. 11/22/2023; 751221, exp. 4/6/2023; 827221, exp. 6/22/2023; 864221, exp. 5/16/2023; oo) SAVA91G, UDI/DI none, Lot numbers: 824221, exp. 6/25/2023; 870221, exp. 5/10/2023; pp) SAVA91H, UDI/DI none, Lot numbers: 790221, exp. 7/29/2023; qq) SAVA91I, UDI/DI none, Lot numbers: 702221, exp. 10/25/2023; 742221, exp. 9/15/2023; rr) SAVA91J, UDI/DI none, Lot numbers: 667221, exp. 10/31/2023; 946231, exp. 2/23/2024; 989231, exp. 1/11/2024; ss) SJOH17I, UDI/DI none, Lot numbers: 696221, exp. 10/31/2023; 747221, exp. 9/10/2023; 778221, exp. 8/10/2023; 817221, exp. 7/2/2023; 863221, exp. 5/17/2023; 988231, exp. 1/12/2024; tt) SJOH28L, UDI/DI none, Lot numbers: 650221, exp. 12/16/2023; 702221, exp. 10/25/2023; 744221, exp. 9/13/2023; 792221, exp. 7/27/2023; 838221, exp. 6/11/2023; 888221, exp. 4/22/2023; 961231, exp. 2/8/2024; 918231, exp. 3/23/2024; uu) SJPH34K, UDI/DI none, Lot numbers: 678221, exp. 11/18/2023; 750221, exp. 9/7/2023; 818221, exp. 7/1/2023; 975231, exp. 1/25/2024; vv) SJVO56A, UDI/DI none, Lot numbers: 763221, exp. 8/25/2023; ww) SJVO56B, UDI/DI none, Lot numbers: 636221, exp. 12/30/2023; 661221, exp. 12/5/2023; 686221, exp. 11/10/2023; 707221, exp. 10/20/2023; 911231, exp. 3/30/2024; 940231, exp. 3/1/2024; 974231, exp. 1/26/2024; xx) SVMJ20L, UDI/DI 00191072142405, Lot numbers: 737221, exp. 9/20/2023; 807221, exp. 7/12/2023; 863221, exp. 5/17/2023; yy) SVMJ20M, UDI/DI 00191072179838, Lot numbers: 903231, exp. 4/7/2024; 955231, exp. 2/14/2024; 681221, exp. 11/15/2023; zz) SVMN60J, UDI/DI 00191072142412, Lot numbers: 654221, exp. 12/12/2023; 734221, exp. 9/23/2023; 784221, exp. 8/4/2023; 836221, exp. 6/13/2023; aaa) SVOH38Q, UDI/DI 00191072156488, Lot numbers: 913231, exp. 3/28/2024; 891231, exp. 4/19/2024; 953231, exp. 2/16/2024; 961231, exp. 2/8/2024; 637221, exp. 12/29/2023; 651221, exp. 12/15/2023; 710221, exp. 10/17/2023; 729221, exp. 9/28/2023; 784221, exp. 7/31/2023; bbb) TNCB10AK, UDI/DI 00191072184948, Lot numbers: 995231, exp. 1/5/2024; ccc) UICD62AM, UDI/DI none, Lot numbers: 959231, exp. 2/10/2024; 879231, exp. 5/1/2024

510(k) numbers

not on file

PMA numbers

not on file

Product code

OEZ

Firm FEI

3003309947

Firm city

Temple Terrace

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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