DeRoyal recalls specific medical procedure packs (STANDARD OB PACK ASCENSION WI, ANGIO PACK, etc.) due to potential outer seal compromise affecting sterility. Affected units have unique reference numbers and lot numbers.
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
DeRoyal is recalling certain medical procedure packs because their outer seals might be open or damaged, which could compromise the sterility of the contents. This poses a risk of infection during medical procedures if the packs are used without proper sterility.
The outer package seal might be open or compromised, which means the medical procedure packs inside could no longer be sterile. If used without proper sterility, this could lead to infections during medical procedures.
Healthcare providers and medical facilities that use these specific procedure packs are most at risk. Patients receiving procedures using these packs could face infection risks if the sterility is compromised.
Check for the product labels: STANDARD OB PACK ASCENSION WI (REF 89-10640), ANGIO PACK (REF 89-10901), and other specific packs listed. Affected units have unique reference numbers and lot numbers provided in the recall notice.
Look for the specific product labels and reference numbers listed in the recall notice to identify affected packs.
The outer package seal could be open or compromised, which affects the sterility of the procedure packs inside.
The recall notice does not specify a remedy, so check the product labels to identify affected packs and contact DeRoyal for further instructions.
Yes, affected units have specific lot numbers listed in the recall notice: 58737945 for REF 89-10640, 58820749 for REF 89-10901, and others.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-2088-2023 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-2088-2023 from DeRoyal. 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.
