CLASS II ONGOING Device recall · Reported 7 Feb 2024 · FDA Enforcement Report
Custom procedural convenience kits and trays recalled
American Contract Systems is recalling Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR, 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-0827-2024
- 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
- Spinal Implants
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
Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit number MMNS20H; f) IR NEURO PACK, kit number OSIN77; g) NEURO SAH, kit number SANE32H; h) NEURO SAH, kit number SANE32I; i) S78FCH CRANI PACK (PS 132432), kit number UICR10U; j) CRANI PACK (PS039498), kit number UICR33AW; k) Laminectomy, kit number UILM77AR; l) DIAGNOSTIC NEURO IR TRAY, kit number WENE21D; m) DIAGNOSTIC NEURO IR TRAY, kit number WENE21F; n) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H; o) DIAGNOSTIC NEURO IR TRAY, kit number WENE21H-01; p) NEURO IR TRAY, kit number WENI56F; q) NEURO IR TRAY, kit number WENI56H; r) NEURO IR TRAY, kit number WENI56H-01
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR recalled?
Yes. American Contract Systems recalled Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR on 29 Nov 2023. The recall is Class II and its status is Ongoing. Recall number Z-0827-2024.
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) AGNE20J, UDI/DI 00191072183187, Lot Numbers: 934231, exp. 10/30/2023; 900231, exp. 4/10/2024; 990231, exp. 1/10/2024; 687221, exp. 11/9/2023; 720221, exp. 10/7/2023; 757221, exp. 8/31/2023; 870221, exp. 5/10/2023; 702221, exp. 10/25/2023; 795221, exp. 7/24/2023; b) LLCR99, UDI/DI 00191072162755, Lot Numbers: 756221, exp. 9/1/2023; 720221, exp. 10/7/2023; 654221, exp. 12/12/2023; 949231, exp. 2/20/2024; c) LLLC26, UDI/DI 00191072171900, Lot Numbers: 749221, exp. 9/8/2023; 695221, exp. 11/1/2023; 997231, exp. 1/3/2024; 920231, exp. 3/21/2024; d) MMCR11J, UDI/DI none, Lot Numbers: 744221, exp. 9/13/2023; 939231, exp. 3/2/2024; 876231, exp. 5/4/2024; e) MMNS20H, UDI/DI none, Lot Numbers: 963231, exp. 2/6/2024; 959231, exp. 2/10/2024; f) OSIN77, UDI/DI 00191072170705, Lot Numbers: 780221, exp. 8/8/2023; 728221, exp. 9/29/2023; 668221, exp. 11/28/2023; 991231, exp. 1/9/2024, 960231, exp. 2/9/2024; 939231, exp. 3/2/2024; UDI/DI 00191072190031, Lot Numbers: 912231, exp. 3/29/2024; 903231, exp. 4/7/2024; g) SANE32H, UDI/DI none, Lot Numbers: 838221, exp. 6/11/2023; 889221, exp. 4/21/2023; h) SANE32I, UDI/DI none, Lot Numbers: 673221, exp. 11/23/2023; 730221, exp. 9/27/2023; 784221, exp. 8/4/2023; 911231, exp. 3/30/2024; 969231, exp. 1/31/2024; i) UICR10U, UDI/DI none, Lot Numbers: 990231, exp. 1/10/2024; 921231, exp. 3/20/2024; 885231, exp. 4/25/2024; j) UICR33AW, UDI/DI none, Lot Numbers: 658221, exp. 12/8/2023; 931231, exp. 3/10/2024; 876231, exp. 5/4/2024; k) UILM77AR, UDI/DI 00191072139184, Lot Numbers: 953231, exp. 2/16/2024; 905231, exp. 4/5/2024; l) WENE21D, UDI/DI 00191072167958, Lot Numbers: 839221, exp. 6/10/2023; m) WENE21F, UDI/DI 00191072167958, Lot Numbers: 819221, exp. 6/30/2023; n) WENE21H, UDI/DI 00191072179326, Lot Numbers: 729221, exp. 9/28/2023; 686221, exp. 11/10/2023; o) WENE21H-01, UDI/DI 00191072179326, Lot Numbers: 980231, exp. 1/20/2024; p) WENI56F, UDI/DI 00191072169341, Lot Numbers: 799221, exp. 7/20/2023; q) WENI56H, UDI/DI 00191072179333, Lot Numbers: 700221, exp. 10/27/2023; r) WENI56H-01, UDI/DI 00191072179333, Lot Numbers: 652221, exp. 12/14/2023; 996231, exp. 1/4/2024
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| 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 |
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