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American Contract Systems Inc.: Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK

Medical DevicesSource: FDA (device) · Date: 2025-10-22

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
American Contract Systems Inc.
Product
Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Recall initiated
2025-09-04
Code info
LKRA40G UDI-DI 191072189691 Lot 8025211 Bag serial number 68154347 * If bag serial number is listed as "N/A", then whole lot is affected
Product quantity
32,433 total
Voluntary mandated
Voluntary: Firm initiated
City
Grimes
State
IA
Country
United States
Event id
97659
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