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B. Braun recalls some two-piece syringes due to potential packaging barrier damage

July 26, 2023 By Sean Whooley

B. Braun Injekt syringes
Certain Injekt syringes fall under this recall. [Image from B. Braun]
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.”

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Recalls, Regulatory/Compliance Tagged With: B. Braun

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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