Custom Anesthesia Kits Recalled Over Sterilization Validation Failure
American Contract Systems recalls 182 anesthesia procedure kits due to improper sterilization assessment of added components. The kits may have compromised functionality, reduced drug efficacy, or elevated sterilant residue.
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 potential safety risks in critical medical procedures. However, no illnesses, injuries, or adverse patient events have been reported. The identified hazards—loss of functionality, potential loss of drug efficacy, and elevated sterilant residue—are based on a validation failure and remain theoretical.
Plain-English summary
American Contract Systems, Inc. is recalling 182 custom procedural convenience kits and trays intended for anesthesia and central line insertion procedures. The recalled products include the HEART ANESTHESIA BUNDLE NS (Kit Number LMHA01V) and the OR/Anesthesia Central Line Insertion Kit (Kit Number UIAN43L), distributed nationwide in the United States.
During an internal investigation, the manufacturer discovered that several components were added to these kits and subjected to the sterilization process without proper validation. No documentation exists to confirm that these added components were suitable for exposure to elevated temperatures and extended sterilization cycles. As a result, the affected components may have compromised functionality, may have reduced drug efficacy if applicable, or may have accumulated higher than specified levels of ethylene oxide sterilant residue.
Affected kits include multiple lot numbers with expiration dates from October 2023 through April 2024. Individuals or facilities with these kits are advised to contact the manufacturer or the FDA for guidance.
The recalled product
- Product
- Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- loss-of-functionality
- loss-of-drug-efficacy
- elevated-sterilant-residue
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 (13)
- a) LMHA01V: No UDI/DI
- Lot Numbers: 702221
- exp. 10/25/223
- 654221
- exp. 12/12/2023
- 954231
- exp. 2/15/2024
- 903231
- exp. 4/7/2024
- b) UIAN43L: No UDI/DI
- Lot Numbers: 654221
- 991231
- exp. 1/9/2024
Distribution
Distributed nationwide across the United States.
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