Neuro IR Tray recalled over unconfirmed sterilization assurance
American Contract Systems Inc is recalling Neuro IR Tray (Model WENI56J) due to inability to confirm sterilization assurance. Loss of functionality could delay or prolong treatment.
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: This is a risk-of-harm medical device where sterilization assurance cannot be confirmed, but no injuries or illnesses have been reported. The Class II classification and potential for loss of functionality in a surgical setting support a High severity rating.
Plain-English summary
American Contract Systems Inc is recalling 120 kits of the Neuro IR Tray, Model No WENI56J, distributed nationwide in Ohio. The company is unable to confirm that sterilization assurance requirements were met during manufacturing or processing.
If the devices are not properly sterilized, they may experience loss or lack of intended functionality. This could result in treatment delays or prolonged treatment courses for patients receiving care with affected trays.
Healthcare facilities and consumers in possession of affected units should contact American Contract Systems Inc or the FDA for instructions regarding the recalled products and proper handling or return procedures.
The recalled product
- Product
- NEURO IR TRAY , Model No WENI56J
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Surgical Tray
- Hazard
- sterilization-assurance-failure
- loss-of-functionality
- treatment-delay
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 (1)
- UDI-DI 00191072217813 Lots 893241 71-051182 71-051813
Distribution
Distributed nationwide across the United States.
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