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.
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 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
- Affected units
- 2
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
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.
See all 19 products in this recall →Related recalls
Same manufacturer · American Contract Systems, Inc.
See all →- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
Same hazard · sterilization failure
See all →- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- HighAmerican Contract Systems Hand Pack Convenience Kit Sterilization Failure
FDA (Devices) · 2024-08-14
- HighSurgical Convenience Kits Recalled for Potential Sterilization Failure
FDA (Devices) · 2024-08-14
- HighSurgical instrument convenience packs recalled for inadequate sterilization validation
FDA (Devices) · 2022-09-14
- HighAmerican Contract Systems Cataract Pack Kits Recalled Due to Insufficient Sterilization Aeration
FDA (Devices) · 2024-08-14
- HighMedical Procedure Kit Recalled Over Potential Sterilization Compromise
FDA (Devices) · 2024-08-14
- HighMedical device convenience packs exposed to unvalidated sterilization cycles
FDA (Devices) · 2022-09-14