Stradis Healthcare recalls sterile catheter insertion trays with preconnected bags due to potential pinhole leaks near seals that could compromise sterility during medical procedures.
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 sterile Foley catheter insertion trays with preconnected bags because the outer bags might have pinhole leaks near the seal. This could lead to a breach in sterility, increasing infection risk during medical procedures.
The outer bag may develop pinhole leaks near the seal during use. This could allow contamination to enter the sterile kit, potentially causing infections in patients during catheter procedures.
Healthcare providers using these specific sterile catheter trays for medical procedures are most at risk. Patients receiving catheter care could be affected if the trays are used without proper sterility.
Check for assembly numbers 33066 or 33068 on the tray. Lot numbers 222782334, 222519530, 222438660 (for 33066) or 222145412, 220551558, 222508466 (for 33068) are also indicators of affected units.
Inspect the outer bag for pinhole leaks near the seal before use. If leaks are found, do not use the tray.
Reach out to Stradis Healthcare for guidance on safe disposal or replacement options.
The recall is due to potential pinhole leaks in the outer bag near the seal, which could compromise sterility during medical procedures.
Check for assembly numbers 33066 or 33068 on the tray. Lot numbers 222782334, 222519530, 222438660 (for 33066) or 222145412, 220551558, 222508466 (for 33068) indicate affected units.
Inspect the outer bag for pinhole leaks near the seal. If leaks are found, do not use the tray. Contact Stradis Healthcare for guidance on safe disposal or replacement.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0931-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0931-2023 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.
