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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 290
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.
Part of a larger recall action
This product is one of 18 recalled by American Contract Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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