Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.Affected ProductThe FDA is aware that B.

Braun Medical, Inc. has issued a letter to affected customers recommending certain spinal anesthesia kits be removed from where they are used or sold.Affected devices:B. Braun PENCAN Spinal Needle Procedure KitsB.

Braun Spinocan Spinal Needle Procedure KitsB. Braun Spinocan Spinal Tray Spinal Needle Anesthesia Procedure KitsFull List of Affected ProductWhat to DoDo not use affected product. Identify affected product, cease use and distribution, and return to B.

Braun Medical, Inc.On April 26, B. Braun Medical, Inc., sent all affected customers a letter recommending the following actions:Immediately examine inventory for affected productDiscontinue use, stop distribution, and quarantine product subject to recall immediatelyReturn affected product to B. BraunIf you have further distributed the product, please forward this notice to your consignees.

This recall is to be extended to the hospital/healthcare facility level. Reason for RecallB. Braun Medical, Inc.

is removing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP from certain convenience kits. Huons Co., Ltd. initiated a recall of Bupivacaine HCL in Dextrose Injection, USP.

Risks of using compromised injectables include infection, inflammatory response and/or reduced anesthetic effectiveness. When used in the neuraxial space, there is a risk of cerebral fluid contamination and meningitis that may progress to encephalitis and emergency conversion to general anesthesia.As of April 24, B. Braun has reported 35 serious injuries and no deaths associated with this issue.Device UseConvenience Kits are two or more separate types of finished products packaged together for the convenience of the user.

Kits (or trays) are often utilized in the surgical arena. Generally, the kits involved in this recall are used for pain management and regional anesthesia.Contact InformationCustomers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact B.

Braun Medical, Inc. at recalls@bbraunusa.com or via phone at (844) 903-6417.Additional FDA ResourcesFDA’s Enforcement ReportMedical Device Recall DatabaseHuons Co., Ltd. Bupivacaine Recall: FDA Enforcement ReportUnique Device Identifier (UDI)The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use.

The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly. How do I recognize a UDI on a label?AccessGUDID database - Identify Your Medical DeviceBenefits of a UDI SystemHow do I report a problem?Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.