Stradis Healthcare recalls catheter angio packs with potential sterility breaches due to incomplete sealing. Affected items include specific model numbers and serials sold through Henry Schein. Consumers should check their kits for proper sealing.
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 catheter angio packs that may have incomplete sealing, risking sterility breaches. This could lead to infections if the kits are used without proper sterility.
The outer bags may not seal properly during manufacturing, potentially allowing contamination. If the kit is used without sterility, it could lead to infections during medical procedures.
Healthcare professionals and medical facilities using the catheter angio packs with the specific model numbers and serials listed. Those handling the kits during medical procedures are most at risk.
Check for the model number 570-2930 and serial numbers starting with 22235490920 on the catheter angio packs. These items were sold through Henry Schein.
Inspect the outer bag for signs of incomplete sealing, such as visible gaps or leaks.
The model number is 570-2930.
Check for the model number 570-2930 and serial numbers starting with 22235490920 on the pack.
Inspect the outer bag for incomplete sealing. If you find signs of a breach, do not use the kit and contact Stradis Healthcare for further 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-0525-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0525-2023 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.