Stradis Healthcare recalls Amnio Tray (Item No. 570-3059) due to potential sterility breaches from incomplete bag sealing. Affected units sold with specific serial numbers.
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 Amnio Trays (Item No. 570-3059) because manufacturing issues might cause the outer bag to be incompletely sealed. This could breach the sterility of the medical kit, risking infection during procedures.
The trays may have outer bags that aren't sealed properly during manufacturing. This could allow contamination, breaking the sterility of the medical kit and increasing infection risk during procedures.
Healthcare providers using Amnio Trays for medical procedures are most at risk. Patients undergoing surgery or procedures using these trays could face infection if the kit is not sterile.
Check for the model number 570-3059 on the tray. Affected units have serial numbers starting with 22257487536.
Inspect the outer bag for signs of incomplete sealing. If the bag appears damaged or not sealed properly, stop using the tray immediately.
The recall is due to manufacturing conditions that may result in the outer bag being incompletely sealed, potentially breaching the sterility of the medical kit.
Check the serial number on the tray. If it starts with 22257487536, stop using it and contact Stradis Healthcare for instructions.
The recall addresses potential infection risk from non-sterile kits, not direct injury. Serious injury is not mentioned in the recall details.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0527-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0527-2023 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.
