FDA-Device2025-10-22Class II
Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
American Contract Systems Inc.
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.
Sold states
US Nationwide distribution in the states of SD, IA, MN, WA, IL.
Affected count
32,433 total
Manufactured in
1601 Se Gateway Dr Ste 120, Grimes, IA, United States
Products
Medical convenience kits Item Number/Description LKRA40G RADIOLOGY PACK
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0182-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief