American Contract Systems Inc. — Medical convenience kits IHDC30R D AND C PACK
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 4, 2025
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
What's affected?
- Product
- Medical convenience kits IHDC30R D AND C PACK
- Lot code
- 8096511
Additional details
IHDC30R UDI-DI 191072226310 lot 8096511 bag serial number N/A * If bag serial number is listed as "N/A", then whole lot is affected
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 32,433 total.
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