Stradis Healthcare recalls venous access packs with potential sterility breaches. Affected units have incomplete sealing causing contamination risks 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 venous access packs that may have incomplete sealing, risking contamination during medical procedures. This could lead to infections if used without proper sterility.
The outer bag may not seal properly during manufacturing, creating a breach in sterility. This could allow contaminants to enter the medical kit during use, potentially causing infections.
Healthcare professionals using these packs for medical procedures are most at risk. Patients receiving procedures with affected packs could face infection risks.
Check for item number 682-1993R1 on the pack. Look for UDI/DI codes M7526821993R11 (case) or M7526821993R10 (kit). Serial numbers starting with 22235491208 indicate affected units.
Identify the item number, UDI/DI codes, and serial numbers to confirm if your pack is affected.
The outer bag may not seal properly, potentially breaching sterility and causing contamination during medical procedures.
Check for item number 682-1993R1, UDI/DI codes M7526821993R11 (case) or M7526821993R10 (kit), and serial numbers starting with 22235491208.
The recall record does not specify a remedy, so contact Stradis Healthcare directly 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-0546-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0546-2023 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.
