Cardiac central line insertion kits lack documented sterilization validation
American Contract Systems is recalling 290 cardiac procedural kits nationwide because components were subjected to sterilization without documented assessment of temperature suitability, potentially causing loss of functionality or efficacy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with theoretical risk of loss of functionality or drug efficacy in a critical medical procedure device. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High). No reported hospitalizations or illnesses.
Plain-English summary
American Contract Systems, Inc. is recalling 290 custom procedural convenience kits and trays for cardiac central line insertion procedures distributed nationwide.
During an internal investigation, the company identified that several components were added to the kits and subjected to the sterilization process without documentation confirming the components were suitable for exposure to elevated temperatures and extended sterilization. This lack of assessment creates three potential risks: the components may lose or lack functionality, lose drug efficacy if applicable, or retain higher than specified ethylene oxide (EO) residuals.
Affected kits include: CENTRAL LINE INSERTION PACK (kit number LLCE52), Adult Central Line Insertion Supply Kit (kit number UICL44N), and Pediatric Central Line Insertion (kit number UIPL77K). Healthcare facilities that received these kits should stop using them and contact American Contract Systems for replacement or guidance.
No injuries or illnesses have been reported to date.
The recalled product
- Product
- Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Insertion, kit number UIPL77K
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- device-malfunction
- loss-of-functionality
- improper-sterilization
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- a) LLCE52
- UDI/DI 00191072030832
- Lot Numbers: 912231
- exp. 11/30/2023
- b) UICL44N
- UDI/DI 00191072142696
- Lot Numbers: 991231
- exp. 1/9/2024
- 891231
- exp. 1/30/2024 c) UIPL77K
- UDI/DI 00191072142801
- Lot Numbers: 748221
- exp. 9/9/2023
- 650221
- exp. 12/16/2023
- 919231
- exp. 3/22/2024
Distribution
Distributed nationwide across the United States.
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