American Contract Systems Recalls ENT Medical Convenience Kits Due to Sterilization Concerns
American Contract Systems is recalling 66 ENT medical convenience kits because humidity readings were out of specification, preventing confirmation of sterilization.
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: The recall involves a medical device where sterilization assurance cannot be confirmed, creating a risk of harm from potential contamination. No injuries or illnesses have been reported, and the agency classification is Class II, which aligns with a High severity rating for risk-of-harm products without reported injury.
Plain-English summary
American Contract Systems, Inc. is recalling 66 units of the ENT, COEN27N Medical convenience kit. The recall was initiated because an inoperable chart recorder resulted in out-of-specification humidity readings in one of the controlled environment areas. Consequently, the company is unable to confirm that product sterilization assurance requirements were met.
The affected products are identified by UDI-DI 00191072206244, Lot 2405092, and an expiration date of 05/09/2025. These units were distributed nationwide in the states of Missouri, Minnesota, Massachusetts, Ohio, and Nebraska.
Consumers and healthcare facilities should check their inventory for these specific lot numbers and stop using the affected kits. They should contact American Contract Systems, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- ENT, COEN27N; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 66
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: 00191072206244
- Lot: 2405092
- Exp: 05/09/2025
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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