Stradis Healthcare recalls catheter packs with item #570-2789 due to potential sterility breaches from incomplete bag sealing. Affected units include specific UDI/DI and serial numbers.
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Stradis Healthcare is recalling catheter packs that may have incomplete bag sealing, risking sterility breaches during medical procedures. This could lead to infections if the kits are used without proper sterility.
The catheter packs may have outer bags that aren't sealed properly during manufacturing. This could allow contamination, breaking the sterility of the medical kits and increasing infection risk during procedures.
Healthcare professionals using catheter packs for medical procedures are most at risk. Patients receiving procedures with these kits could face infection if sterility is compromised.
Check for item number 570-2789 on the catheter pack. Look for UDI/DI codes H65857027891 (case) or M75257027890 (kit), and serial numbers starting with 22252491561.
Identify the item number, UDI/DI codes, and serial numbers to confirm if your catheter pack is affected.
The recall is for potential sterility breaches, which could lead to infections if the kits are used without proper sterility. However, the risk is low and not all units are affected.
Check for item number 570-2789, UDI/DI codes H65857027891 (case) or M75257027890 (kit), and serial numbers starting with 22252491561.
The recall does not specify a remedy, so check with Stradis Healthcare for guidance on next steps.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0518-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0518-2023 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.
