Stradis Healthcare recalls bone marrow kits with item #570-3092 due to potential sterility breaches from incomplete bag sealing. Affected kits may not be sterile, risking infection during medical procedures.
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 bone marrow kits that may have incomplete bag sealing, risking sterility breaches. This could lead to infections if used in medical procedures without proper sterilization.
The kits may have outer bags that aren't sealed properly during manufacturing. This could allow contamination, making the kit non-sterile and increasing infection risk during medical procedures.
Healthcare professionals using bone marrow kits for medical procedures are most at risk. Patients receiving these kits could face infection if the kit isn't sterile.
Check for item number 570-3092 on the kit. The UDI/DI (case) is H65857030921 and UDI/DI (kit) is M75257030920. Serial/lot numbers start with 22231491193.
Inspect the outer bag for signs of incomplete sealing, such as gaps or leaks.
The recall states the kit may not be sterile due to potential bag breaches, so it should not be used until confirmed safe.
Look for item number 570-3092, UDI/DI (case) H65857030921, UDI/DI (kit) M75257030920, or serial/lot numbers starting with 22231491193.
The recall does not specify a remedy, so check the kit's seal and contact Stradis Healthcare for guidance.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0532-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0532-2023 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.
