DeRoyal recalls sterile pelvic exam procedure packs (REF 89-6219) due to potential compromised outer seals risking contamination. Affected units include specific lot numbers and GTINs.
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
DeRoyal is recalling sterile pelvic exam procedure packs labeled REF 89-6219 because the outer packaging might not seal properly, risking contamination. This could lead to infections if used without proper sterility.
The outer package seal might be open or damaged, which could allow contaminants to enter the sterile procedure pack. This breaks the sterility required for medical procedures, increasing infection risk.
Healthcare providers using these packs for pelvic exams are most at risk. Patients receiving procedures with these packs could face infection if sterility is compromised.
Check for the label 'PELVIC EXAM TRAY, REF 89-6219' on the outer packaging. Affected units have specific lot numbers (58807114) and GTINs (50749756664382 for carton, 00749756664387 for unit).
Inspect the outer packaging for any signs of an open or damaged seal.
The outer package seal could be open or compromised, which affects the sterility of the procedure pack inside.
Check the package seal for damage or openness. If the seal is compromised, do not use the pack.
Look for the label 'PELVIC EXAM TRAY, REF 89-6219' with specific lot numbers (58807114) and GTINs (50749756664382 for carton, 00749756664387 for unit).
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-2089-2023 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-2089-2023 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.
