Class II Recall

Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB

Summary

The FDA issued a Class II for Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IM by American Contract Systems, Inc.. Reason: During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization proces.

Details

Source

Device Recall

External ID

Z-0818-2024

Action Date

2024-02-07

Status

Ongoing

Product Description

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

Lot/Code Info: 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

Quantity Affected: 12291 units

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.

Distribution

US Nationwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2023-11-29

Company

American Contract Systems, Inc.

Temple Terrace, FL

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 221 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-0818-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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