FDA recall Z-0116-2024

Product

DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit

Reason for recall

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.

Distribution

Pennsylvania

Key facts

Status

Ongoing

Initiation date

2023-09-18

Report date

2023-10-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0116-2024