Medical Convenience Kit Recalled for Failed Sterilization Assurance Validation
American Contract Systems, Inc. is recalling the Hand Pack AKHD97C medical convenience kit because an inoperable chart recorder caused humidity readings to fall outside specifications, preventing confirmation of sterilization assurance.
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 device where sterilization assurance cannot be confirmed, representing a risk-of-harm product. No illnesses or injuries reported; the hazard is theoretical pending verification of actual sterilization status.
Plain-English summary
American Contract Systems, Inc. is recalling the Hand Pack, AKHD97C medical convenience kit due to an inability to confirm that sterilization assurance requirements were met.
The recall was initiated after the company identified an inoperable chart recorder in one of its controlled environment areas during the sterilization process. The malfunctioning recorder resulted in humidity readings that fell outside acceptable specifications. Because of these out-of-specification readings, the manufacturer cannot verify that sterilization requirements were properly satisfied.
The affected Hand Pack units (Lot 2405102, expiration May 10, 2025) were distributed to medical facilities in Missouri, Minnesota, Massachusetts, Ohio, and Nebraska. Consumers who have received this product should discontinue use and contact American Contract Systems, Inc. regarding return or replacement options.
The recalled product
- Product
- Hand Pack, AKHD97C; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Convenience Kit
- Hazard
- sterilization-failure
- contamination-risk
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: 00191072217660
- Lot: 2405102
- Exp: 05/10/2025
Distribution
Distributed nationwide across the United States.
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