American Contract Systems recalls LKRA40G RADIOLOGY PACK medical kits that may have been re-gassed more than once during sterilization, risking product safety and effectiveness.
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.
American Contract Systems is recalling medical convenience kits (LKRA40G RADIOLOGY PACK) because they were re-gassed more than once during sterilization. This could mean the kits aren't safe or effective for medical use.
The kits were re-gassed (sterilized) more than once after a problem occurred during the initial sterilization process. This means the kits haven't been tested to ensure they're safe or effective after multiple sterilization cycles.
Healthcare professionals using these medical kits are likely affected. Patients receiving treatments with these kits could be at risk if the kits are not safe.
Check for the item number LKRA40G and the bag serial number 68154347. If the bag serial number is listed as 'N/A', the entire lot is affected.
Look for the item number LKRA40G and bag serial number 68154347 on the kit.
The kits were re-gassed more than once during sterilization, which hasn't been validated for safety and effectiveness.
Check for item number LKRA40G and bag serial number 68154347. If the bag serial number is listed as 'N/A', the entire lot is affected.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0182-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0182-2026 from American Contract Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
