Recall of angiography packs/trays due to potential exposure to multiple sterilization cycles without validation. Affected items have specific tray numbers and lot codes.
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems is recalling various angiography packs and trays that were exposed to multiple sterilization cycles without proper validation. This could lead to contamination or failure of the medical devices during use.
The packs and trays were sterilized multiple times without validation, which could cause them to become contaminated or fail during medical procedures. This might lead to infection or improper device function.
Healthcare professionals using these angiography packs and trays in medical procedures are most at risk. Patients receiving procedures with these items may be affected if the devices fail.
Check for specific tray numbers, sterilization lots, lot numbers, and bag serial numbers listed in the recall notice. Affected items include those with the tray numbers and codes listed above.
Look for the tray number, sterilization lot, lot number, and bag serial number on the product to determine if it's affected.
The product was exposed to multiple sterilization cycles without validation, which could lead to contamination or failure during medical procedures.
Check for the specific tray numbers, sterilization lots, lot numbers, and bag serial numbers listed in the recall notice.
The recall notice does not specify a remedy, so contact American Contract Systems for further instructions.
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-1689-2022 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1689-2022 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.
