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Recall Observatory FDA recall evidence

Device product

Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK

Z-0182-2026

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-0182-2026

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: LKRA40G UDI-DI 191072189691 Lot 8025211 Bag serial number 68154347 * 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.