Stradis Healthcare recalls Micro Introducer Kit (Item 525-038) due to potential sterility breaches from incomplete bag sealing. Affected units have specific serial numbers and UDI codes.
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 its Micro Introducer Kit (Item 525-038) because manufacturing issues might cause the outer bag to be incompletely sealed. This could breach the kit's sterility, risking infection during medical procedures.
The kit's outer bag may not seal properly during manufacturing, allowing contamination. This breach in sterility could lead to infections if the kit is used in medical procedures without proper sterilization.
Healthcare professionals using this kit for cardiovascular procedures are most at risk. Patients receiving procedures with the recalled kit could face infection.
Check for the model number 525-038 on the kit. Look for serial number 22251491752 or UDI codes M7525250381 (case) and M7525250380 (kit).
Look for serial number 22251491752 on the kit packaging or label.
The recall states the kit may have incomplete sealing, risking sterility breaches. Do not use until confirmed safe by the manufacturer.
The recall does not specify a remedy, so contact Stradis Healthcare directly for guidance.
Check for serial number 22251491752 or UDI codes M7525250381 (case) and M7525250380 (kit).
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0500-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0500-2023 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.
