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Recall Observatory FDA recall evidence

Device product

Medical convenience kits UDPG88W PICC G-TUBE PACK-230209

Z-0186-2026

September 04, 2025

Class II

Product summary

Firm
American Contract Systems Inc.
Event
Event 97659
Status
Ongoing
Classification
Class II
Quantity
32,433 total
Official record key
device-enforcement:Z-0186-2026

Official wording

Reason: 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.

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

Distribution pattern: US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.