DeRoyal recalls CV Basin Set Packs with non-sterile sternum saw blades marked by green stickers. These surgical packs may cause infections if used in procedures.
Sternum saw blades within procedure packs are not sterile. The surgical saw blade has a green non-sterile sticker.
DeRoyal is recalling surgical procedure packs that include sternum saw blades with non-sterile stickers. Using these blades in surgery could lead to infections since they are not sterile.
Surgical saw blades in these packs are not sterile, as indicated by a green sticker. If used during procedures, they could introduce infections into the patient's body.
Surgical teams using DeRoyal CV Basin Set Packs with the listed reference numbers and lot codes are affected. Patients undergoing surgery with these packs face infection risks.
Check for CV Basin Set Packs with reference numbers a) through f) and the specific lot codes listed in the recall notice. The blades have a green non-sterile sticker.
Look for a green sticker on the sternum saw blade in the pack to confirm non-sterile status.
The sternum saw blades in these packs are not sterile, as indicated by a green non-sterile sticker. This could lead to infections during surgery.
Check for CV Basin Set Packs with reference numbers a) through f) and the specific lot codes listed in the recall notice. The blades have a green non-sterile sticker.
The recall does not specify a remedy, so contact DeRoyal directly for guidance on next steps.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1138-2021 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1138-2021 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.
