B Braun Medical recalled 10,130 ESPOCAN spinal/epidural trays nationwide after discovering potential for the catheter connector lid to be in an incorrect position. The recall covers multiple product codes and UDI numbers. Healthcare providers must stop using affected units and follow manufacturer instructions for remediation.
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
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ESPOCAN tray systems are used to perform combined spinal and epidural anesthesia procedures. They enable precise needle placement and catheter connection in a single setup.
A lid-position error in the catheter connector can compromise the integrity of the connection, potentially impacting patient safety during anesthesia.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals and clinics must halt use of affected trays and follow recall instructions, which may affect scheduling and procurement.
Look on the device label for product code and UDI numbers; recall letters provide full guidance
Remedies are issued per recall procedures; facilities should expect guidance from the manufacturer and regulatory bodies
Keep copy of recall notice, product labels, lot numbers, and correspondence with the manufacturer
Brand: B BRAUN MEDICAL. Product: ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. Spinal Needle with Marking and Centering Sleeve, and 19 Ga. closed-tip PERIFIX FX Springwound Epidural Catheter. Product Code: ES1725KFX. UDI-DI (Primary): 04046955899531. UDI-DI (Unit of Use): 04046955899548. Lot Numbers: 0062005817, 0062011662, 0062011663, 0062014354, 0062011664. Distribution: Nationwide to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN
No incidents or injuries are reported in the provided data.
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