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 5,770 PERIFIX FX Epidural Anesthesia Trays on September 18, 2025. The recall stems from a potential issue with the lid of the catheter connector. This defect may cause improper operation during procedures, posing serious health risks.
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 includes multiple models, specifically product code CESK and several REF numbers including 551028, 551474, and 551630. The trays were distributed to hospitals nationwide, with sales occurring across various states. The devices were sold under the brand B Braun Medical.
The recall concerns the potential for the lid of the catheter connector to be in the incorrect position. This could compromise the effectiveness of epidural anesthesia, leading to severe complications during medical procedures.
There have been no specific reported incidents or injuries associated with this recall. The nature of the defect raises significant concerns for patient safety, warranting immediate action.
Patients and healthcare providers should stop using the affected trays immediately. Follow the manufacturer’s recall instructions and contact B Braun Medical or your healthcare provider for further guidance.
For more information, consumers can visit the FDA recall page or contact B Braun Medical directly. The recall notification method is through letters.
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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