American Contract Systems Inc. — Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
⚠️ 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 Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
- Lot code
- 8003911
Additional details
UICL44P UDI-DI 191072194268 Lot 8003911 Bag serial number N/A; UICL44R UDI-DI 191072234018 Lot 8317711 Bag serial number 68244081 * If bag serial number is listed as "n/a", then entire lot is affected
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 32,433 total.
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