Medical Device Recall: Medical convenience kits IHDC30R D AND C PACK
American Contract Systems Inc. · September 4, 2025
Reason for Recall
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
Distribution
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
States Affected
NATIONWIDE
Quantity Affected
32,433 total
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0187-2026
Status: ongoing
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