Stradis Healthcare recalls probe covers with gel packs (Item No. 525-071) due to potential sterility breaches from incomplete sealing. Affected units include specific serial numbers and lot 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 probe covers with gel packs used in surgery because they might not seal properly, risking contamination during procedures. This could lead to infections if the sterile packaging is compromised.
The outer bag may not seal completely during manufacturing, which could allow contamination of the sterile surgical kit. This might lead to infections if the kit is used without proper sterility.
Surgical teams and hospitals using the specific probe covers with gel packs (Item No. 525-071) are affected. The risk is low for most users since the breach is unlikely to occur in normal use.
Check for the item number 525-071 on the probe cover with gel pack. Affected units have specific serial numbers (22252491061) and lot codes (M7525250711 or M7525250710).
Look for the item number 525-071 on the probe cover with gel pack.
The outer bag may not seal completely during manufacturing, which could lead to contamination of the sterile surgical kit.
The recall does not specify a remedy, so check the product details to confirm if it's affected and contact Stradis Healthcare for further instructions.
Affected units have the item number 525-071, serial number 22252491061, or lot codes M7525250711 or M7525250710.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0501-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0501-2023 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.
