Diagnostic Neuro IR Tray recalled for unconfirmed sterilization
American Contract Systems Inc is recalling 170 Diagnostic Neuro IR Tray kits due to inability to confirm sterilization assurance requirements were met. The units may lose functionality and cause treatment delays.
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: This is a Class II recall involving a medical device with potential risk of harm due to unconfirmed sterilization. No illnesses or injuries have been reported, and the hazard is theoretical but serious for diagnostic equipment.
Plain-English summary
American Contract Systems Inc is recalling 170 Diagnostic Neuro IR Tray kits (Model No WENE21) distributed in Ohio. The company cannot confirm that product sterilization assurance requirements were met. This could lead to possible loss or lack of functionality, resulting in delayed or prolonged treatment.
The affected product includes lot numbers: 960241, 71-050727, 71-051234, 71-051771, 71-052322, 71-052501, 71-052705. Healthcare providers and facilities that have received affected units should stop using them and contact American Contract Systems Inc for instructions regarding returns or replacement.
The recalled product
- Product
- DIAGNOSTIC NEURO IR TRAY , Model No WENE21
- Manufacturer
- American Contract Systems Inc
- Affected units
- 170
Distribution
Part of a larger recall action
This product is one of 32 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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