DeRoyal recalls specific lots of Heart Cath Procedure Packs due to mislabeled 0.5% Bupivacaine instead of 1% Lidocaine. Affected units contain lot numbers 54310362 or 54366825 expiring 01/01/2022.
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
DeRoyal is recalling certain lots of Heart Cath Procedure Packs because they contain 0.5% Bupivacaine instead of the intended 1% Lidocaine. This mislabeling could lead to incorrect medication dosing during procedures, potentially causing adverse effects.
The procedure pack was mislabeled with 0.5% Bupivacaine instead of 1% Lidocaine. Bupivacaine is a stronger local anesthetic that could cause severe complications if used in cardiac procedures at the intended concentration.
Healthcare professionals using the DeRoyal Heart Cath Procedure Packs for cardiac procedures are most at risk. Patients receiving these packs during surgery may be affected if the wrong medication is administered.
Check for lot numbers 54310362 or 54366825 on the DeRoyal Heart Cath Procedure Pack packaging. These units expire January 1, 2022.
Look for lot numbers 54310362 or 54366825 on the DeRoyal Heart Cath Procedure Pack.
The intended medication is 1% Lidocaine, but the recalled packs contain 0.5% Bupivacaine due to mislabeling.
Check for lot numbers 54310362 or 54366825 on the packaging, which expire January 1, 2022.
The recall record does not specify a remedy, so contact DeRoyal directly for guidance.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-1833-2021 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-1833-2021 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.
