Stradis Healthcare recalls CYSTO SET UP PACKs with potential outer bag pinholes causing sterility breaches. Affected units include specific assembly numbers and lot numbers. Stop using immediately to avoid infection risks.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Stradis Healthcare is recalling CYSTO SET UP PACKs that may have pinhole leaks in the outer bag, risking a breach in sterility. This could lead to infections if used for medical procedures. Affected units have specific assembly numbers and lot numbers listed in the recall.
The outer bag may have pinholes near the seal, which can breach the sterility of the kit. This risk is serious because medical procedures require sterile environments to prevent infections.
Medical professionals using the CYSTO SET UP PACKs for procedures are most at risk. Patients receiving these kits could face infections if the sterility is compromised.
Check for assembly number 570-1130 and lot numbers listed: 222990332, 222692396, 222990334, 221013080, 222529321, 220984273, 222692395, 222368551, 220982614, 222992161.
Discard the CYSTO SET UP PACK if you have the affected assembly numbers or lot numbers listed.
The outer bag may have pinholes near the seal, which can breach the sterility of the kit and lead to infections during medical procedures.
Discard the CYSTO SET UP PACK immediately if it has the affected assembly numbers or lot numbers listed in the recall.
Check for assembly number 570-1130 and lot numbers: 222990332, 222692396, 222990334, 221013080, 222529321, 220984273, 222692395, 222368551, 220982614, 222992161.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0933-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0933-2023 from Stradis Healthcare. 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.
