Stradis Healthcare recalls pacemaker packs with item number 570-2793 due to potential sterility breaches from incomplete bag sealing. Affected units include specific UDI/DI and 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 pacemaker packs with item number 570-2793 because the outer bags may not seal properly, risking contamination during medical procedures. This could lead to infections if the sterile kit is used without proper sterility.
The outer bags may not seal completely during manufacturing, which could allow contamination. If the kit is used without proper sterility, it might cause infections during medical procedures.
Healthcare professionals using these pacemaker packs for medical procedures are most at risk. Patients receiving surgery with the recalled packs could face infection if the kit is not sterile.
Check for item number 570-2793 on the pacemaker pack. Look for UDI/DI codes: H65857027931 (case) and M75257027930 (kit). Serial numbers start with 22241489575.
Identify the item number, UDI/DI codes, and serial numbers to confirm if your pacemaker pack is affected.
The outer bags may not seal completely during manufacturing, which could lead to contamination if the kit is used without proper sterility.
Check the product details for the item number, UDI/DI codes, and serial numbers to see if it's affected. If it is, contact Stradis Healthcare for further instructions.
The recall is for potential sterility breaches, which could lead to infections during medical procedures. Serious injury is not mentioned in the recall notice.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0519-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0519-2023 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.
