B. Braun issued an urgent field safety notice in Europe related to potential issues with certain two-piece syringes.
The company’s notice said it decided to proactively recall a batch combination of the syringes. B. Braun identified a number of batches of its Exadoral, Henke-JECT, Norm-Ject and Injekt devices.
In the course of postmarket surveillance and internal quality checks, the company identified the reason for the recall. For a subset of the batch combinations, the sterile packaging barrier may be damaged.
B. Braun received no reports of patient, user or third-party injuries. However, the company says the deviation might risk local, regional and systemic infections. These could lead to patient death. In view of those risks, B. Braun decided to recall the affected devices.
The company said the effect remains limited to the article batches mentioned in the notice. No other batches or products are affected.
B. Braun asked customers to identify, quarantine and return all affected articles. They should not use affected devices anymore.
“We believe in improving people’s health through everything we do,” the notice said. “Patient and user safety is our highest priority. Kindly accept our apologies for any inconveniences caused and thank you in advance for your cooperation to resolve this matter quickly.”