IR Procedure Pack Recalled Due to Sterilization Assurance Failure
American Contract Systems recalls IR Procedure Pack (Lot 2405102, expiration 05/10/2024) because it cannot confirm sterilization requirements were met. An inoperable chart recorder caused humidity levels to be out-of-specification.
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 without reported illnesses or injuries. The inability to confirm sterilization of a medical device due to environmental monitoring equipment failure constitutes a risk-of-harm situation. This meets Score 3 criteria: risk-of-harm product without yet-reported injury.
Plain-English summary
American Contract Systems, Inc. is recalling the IR Procedure Pack, CEAT19W (Lot 2405102, expiration 05/10/2024). This medical convenience kit was distributed nationwide in Missouri, Minnesota, Massachusetts, Ohio, and Nebraska.
The recall was initiated because an inoperable chart recorder resulted in humidity readings that were out-of-specification in one of the controlled environment areas. As a result, American Contract Systems cannot confirm that sterilization assurance requirements were met for these products.
Those who have this product should verify they have the affected lot number and contact American Contract Systems for further information.
The recalled product
- Product
- IR Procedure Pack, CEAT19W; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device
- Affected units
- 1
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 (3)
- UDI-DI: 00191072184566
- Lot: 2405102
- Exp: 05/10/2024
Distribution
Part of a larger recall action
This product is one of 19 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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