CLASS II ONGOING Device recall · Reported 7 Feb 2024 · FDA Enforcement Report
Procedural convenience kits and trays, cardiac, labeled as recalled
American Contract Systems is recalling Procedural convenience kits and trays, cardiac, labeled as: a) EP Lab BI V Implant Pack, distributed nationwide in the US. The recall was initiated on 29 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0818-2024
- FDA event ID
- 93656
- Recalling firm
- American Contract Systems, Temple Terrace, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Nov 2023
- FDA classified
- 26 Jan 2024
- Reported
- 7 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Pacemakers & Defibrillators
Timeline
| 29 Nov 2023 | Recall initiated by company | |
| 26 Jan 2024 | Classified by FDA | +58 days |
| 7 Feb 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
17 other products · FDA event 93656More recalls from American Contract Systems
All 210| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Convenience Kits, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, D & C PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | medical procedure kits and trays labeled as: Crani Pack recalled | American Contract Systems | Sterility | IA, MN, MO |
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