Z-0186-2026 Class II Ongoing
FDA device recall Z-0186-2026 was initiated by American Contract Systems Inc. on September 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
- October 22, 2025
- Initiation Date
- September 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,433 total
Product Description
Medical convenience kits UDPG88W PICC G-TUBE PACK-230209
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
UDPG88W UDI-DI 191072216359 lot 7935611 bag serial number N/A * If bag serial number is listed as "N/A", then whole lot is affected