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 2,450 pain management trays on September 18, 2025. The recall stems from a potential issue with the catheter connector lid positioning. This defect poses a high risk to patient safety.
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 a pain management tray with product code SESK. It includes various models distributed to hospitals nationwide.
The recall involves a potential misalignment of the lid on the catheter connector. This incorrect positioning could compromise the device's effectiveness.
No injuries or incidents have been reported as a result of this issue. The recall is a precautionary measure.
Patients and healthcare providers must stop using the device immediately. Contact B Braun Medical or your healthcare provider for further instructions.
For more information, visit the recall notice at the FDA website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0124-2026.
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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