Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
B Braun Medical recalled the PERIFIX FX Continuous Epidural Anesthesia Tray on September 18, 2025. The recall affects a potential safety issue with the catheter connector. No injuries have been reported but the hazard level is classified as high.
Potential for the lid of the catheter connector to be in the incorrect position.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B BRAUN MEDICAL INC or your healthcare provider for instructions. Notification method: Letter
The recalled product is the PERIFIX FX Continuous Epidural Anesthesia Tray, including a 17 Ga. x 3-1/2 in. Tuohy Epidural Needle and a 19 Ga. Closed Tip Catheter. The product code is CE17TBFC and it was distributed nationwide.
The recall stems from a potential misalignment of the lid on the catheter connector. This situation may pose serious risks during medical procedures.
No injuries or incidents have been reported related to this recall. The recall is precautionary in nature.
Patients and healthcare providers should stop using the device immediately. Contact B Braun Medical Inc or your healthcare provider for further instructions.
For more information, visit the FDA recall page at the provided URL. Alternatively, reach out to B Braun Medical Inc directly.
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Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Labeling: Incorrect or Missing Lot and/or Exp Date