DeRoyal recalls three medical procedure packs (CATH ANGIOGRAPHY DRAPE PACK, CHOLANGIOGRAPHY KIT, CATH LAB PACK) due to potential compromised outer seals affecting sterility. Affected units have specific 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 three medical procedure packs that could have open or compromised outer seals, risking infection during surgery. This is serious because medical procedures require sterile environments.
The outer packaging seal might be open or damaged, which could allow contaminants to enter the sterile procedure pack. This risks infection during medical procedures that require aseptic conditions.
Healthcare professionals using these packs for procedures like angiography or cholangiography are most at risk. Patients undergoing these procedures could face infection if the packs are not sterile.
Check for the product names: CATH ANGIOGRAPHY DRAPE PACK (REF 89-7102), CHOLANGIOGRAPHY KIT (REF 89-7322), or CATH LAB PACK (REF 89-9183). Look for specific lot numbers: 58806701, 58821231, or 58741944.
Inspect the outer packaging for any signs of being open or compromised.
The outer package seal could be open or compromised, which affects the sterility of the procedure pack inside.
CATH ANGIOGRAPHY DRAPE PACK (REF 89-7102), CHOLANGIOGRAPHY KIT (REF 89-7322), and CATH LAB PACK (REF 89-9183).
Check for the specific reference numbers and lot numbers listed in the recall notice.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-2090-2023 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-2090-2023 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.