Z-0177-2026 Class II Ongoing
FDA device recall Z-0177-2026 was initiated by American Contract Systems Inc. on Sep 4, 2025 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 32,433 total.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 22, 2025
- Initiation Date
- Sep 4, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,433 total
Product Description
Medical convenience kits Item Number/Description UICL44P ADULT CENTRAL LINE INSERTION SUPPLY KIT UICL44R ADULT CENTRAL LINE INSERTION SUPPLY KIT
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 Pattern
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0177-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026