Recalled Port Insertion Packs may have been exposed to multiple sterilization cycles without validation, risking contamination. Affected units include specific tray numbers and sterilization lots.
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
American Contract Systems is recalling certain Port Insertion Packs that may have been exposed to multiple sterilization cycles without proper validation. This could lead to contamination risks for users during medical procedures.
The packs may have been exposed to multiple sterilization cycles without proper validation, which could lead to contamination. This risk is particularly concerning for medical procedures where sterile conditions are critical.
Healthcare professionals using these packs for medical procedures are likely affected. Patients receiving treatments with these packs face the highest risk of contamination.
Check for tray number GSPI26E, sterilization lot 2108202, and lot number 770211. The specific bag serial numbers 44336884-005 and 44336909-005 are also part of the affected units.
Verify the tray number, sterilization lot, lot number, and bag serial number against the listed affected units.
The recall indicates potential contamination risk due to improper sterilization cycles. Affected units should not be used until confirmed safe.
Check the product details against the listed affected units. If you have an affected unit, stop using it and contact the manufacturer for guidance.
Look for tray number GSPI26E, sterilization lot 2108202, lot number 770211, and bag serial numbers 44336884-005 or 44336909-005.
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-1696-2022 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-1696-2022 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.
