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 defect in the catheter connector lid. Patients and healthcare providers must stop using the device immediately.
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 recall involves the PERIFIX FX Continuous Epidural Anesthesia Tray with product code CE17TKFCPS. The tray includes a 17 Ga. x 3-1/2 in. Tuohy epidural needle and a 19 Ga. closed tip epidural catheter. The affected products were distributed nationwide.
The potential hazard involves the lid of the catheter connector being incorrectly positioned. This malfunction can lead to improper use during epidural anesthesia.
There are no reported incidents associated with this recall, but the risk is classified as high due to potential complications in anesthesia administration.
Stop using the device immediately. Contact B Braun Medical or your healthcare provider for further instructions and follow the recall notifications.
For more information, contact B Braun Medical at the provided customer service number. Visit the FDA's website for additional details.
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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