DeRoyal recalls surgical kits with potential sterile packaging damage from syringe luer tip issues. Affected lots include specific expiration dates and serial numbers.
DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe.
DeRoyal is recalling certain surgical head and neck procedure kits because the sterile packaging could be damaged if the syringe's luer tip is compromised. This risk could lead to contamination during medical procedures.
The sterile packaging barrier could be damaged if the syringe's luer tip is damaged, potentially allowing contaminants to enter the procedure kit. This risk occurs during normal use when the syringe is handled or stored improperly.
Surgical professionals using the DeRoyal Head and Neck procedure kit with specific lot numbers and expiration dates are most at risk. Patients receiving procedures with this kit may also be affected.
Check for the lot codes 59205650 or 59496207 with expiration dates of November 1, 2027, on the DeRoyal Head and Neck procedure kit (REF 89-4473).
Look for lot codes 59205650 or 59496207 with expiration date November 1, 2027 on the DeRoyal Head and Neck procedure kit (REF 89-4473).
The recall is due to potential damage to the sterile packaging barrier from the syringe's luer tip, which could lead to contamination during medical procedures.
Check the lot codes and expiration date. If affected, contact DeRoyal for further instructions.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0116-2024 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0116-2024 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.
