Reported Feb 7, 2024 · Ongoing
Procedural convenience kits and trays, cardiac, labeled as
American Contract Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Contract Systems, Inc. · 7802 E Telecom Pkwy · Temple Terrace, FL · 33637-0928
Is this the product you have?
Procedural convenience kits and trays, cardiac, labeled as
26 of 26 products
| # | Product as published |
|---|---|
| 1 | EP LAB BI V IMPLANT PACK, kit number AGBI64J |
| 2 | LAB DEVICE IMPLANT, kit number AGDI40J |
| 3 | LAB DEVICE IMPLANT, kit number AGDI40K |
| 4 | MINOR VASCULAR, kit number AGMV26O |
| 5 | OPEN HEART ACCESSORY, kit number AGOH98Q |
| 6 | OPEN HEART ACCESSORY, kit number AGOH98R |
| 7 | OPEN HEART ACCESSORY, kit number AGOH98S |
| 8 | PERIPHERAL VASCULAR, kit number AGPV28O |
| 9 | PERIPHERAL VASCULAR, kit number AGPV28P |
| 10 | MINOR VASCULAR, kit number AHMV26J |
| 11 | MINOR VASCULAR, kit number AHMV26K |
| 12 | HEART PACK - 205947, kit number ANCV78AX |
| 13 | HEART PACK - 205947 , kit number ANCV78AX1 |
| 14 | HEART PACK - 205947 Post Open-Heart, kit number ANHK74N |
| 15 | OPEN HEART EAST PACK, kit number BHOH43 |
| 16 | 74OFF PUMP CABG PACK, kit number BHOP48 |
| 17 | PACEMAKER PACK, kit number BHPM60 |
| 18 | FORBES EP LAB DEVICE IMPLANT PK, kit number FBDI42K |
| 19 | T AND A PACK AGH ASC, kit number FBDI42L |
| 20 | T AND A PACK AGH ASC, kit number FBDI42M |
- Lot codes and dates
26 of 26 products
Products covered by this recall # Barcodes Product as published 1 0019107247578AGBI64J, 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 2 00191072154668AGDI40J, 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 3 00191072188168AGDI40K, UDI/DI 00191072188168, Lot numbers: 910231, exp. 3/31/2024; 904231, exp. 4/6/2024 4 00191072179777AGMV26O, 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 5 00191072159419AGOH98Q, UDI/DI 00191072159419, Lot numbers: 846221, exp. 6/3/2023 6 00191072169754AGOH98R, UDI/DI 00191072169754, Lot numbers: 742221, exp. 9/15/2023; 772221, exp. 8/16/2023; 794221, exp. 7/25/2023 7 00191072179784AGOH98S, 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 8 AGPV28O, UDI/D I00191072137210, Lot numbers: 847221, exp. 6/2/2023 9 00191072179791AGPV28P, UDI/DI 00191072179791, Lot numbers: 771221, exp. 8/17/2023; 961231, exp. 2/8/2024; 696221, exp. 10/31/2023 10 00191072137586AHMV26J, UDI/DI 00191072137586, Lot numbers: 735221, exp. 9/22/2023; 790221, exp. 7/29/2023; 839221, exp. 6/10/2023 11 00191072179807AHMV26K, 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 12 00191072182692ANCV78AX, UDI/DI 00191072182692, Lot numbers: 706221, exp. 10/21/2023 13 00191072182692ANCV78AX1, UDI/DI 00191072182692, Lot numbers: 647221, exp. 12/19/2023 14 00191072191472ANHK74N, UDI/DI 00191072191472, Lot numbers: 706221, exp. 10/21/2023 15 00191072160690BHOH43, 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 16 00191072164131BHOP48, 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 17 00191072160799BHPM60, 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 18 00191072169761FBDI42K, 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 19 00191072189905FBDI42L, UDI/DI 00191072189905, Lot numbers: 920231, exp. 7/31/2023; 942231, exp. 7/31/2023 20 00191072192066FBDI42M, UDI/DI 00191072192066, Lot numbers: 899231, exp. 4/11/2024 - Amount recalled
- 12291 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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