Stradis Healthcare recalls Basin Pack item 570-1692 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 Basin Pack item 570-1692 because manufacturing issues could cause the outer bag to be incompletely sealed. This might breach the sterility of the medical kit, increasing infection risk during procedures.
The manufacturing process may leave the outer bag of the medical kit incompletely sealed. This could allow contamination, breaking the sterility of the kit and potentially causing infections during surgical or medical procedures.
Healthcare professionals and facilities using the Basin Pack item 570-1692 are most at risk, as improper sterility could lead to infections during medical procedures.
Check for the Basin Pack item number 570-1692. Look for UDI/DI (case) H65857016921 or UDI/DI (kit) M75257016920. Serial/Lot Numbers: 22257490755.
Identify the Basin Pack item number 570-1692 with UDI/DI codes H65857016921 (case) or M75257016920 (kit) and serial number 22257490755.
The recall is due to potential manufacturing issues that may cause the outer bag to be incompletely sealed, risking sterility breaches in medical kits.
Check for Basin Pack item 570-1692 with UDI/DI (case) H65857016921, UDI/DI (kit) M75257016920, and serial number 22257490755.
The recall record does not specify a remedy, so 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-0507-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0507-2023 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.
