Recall Z-1576-2015— B. Braun Medical, Inc.

Class II FDA medical device recall by B. Braun Medical, Inc., initiated 2015-03-27, terminated 2017-02-01. FDA's recall record names no specific 510(k) clearance for this event. Product: CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural Anesthesia Tray, ESPOCAN Combined Spinal and Epidural Anesthesia Tray, PERIFIX Continuous Epidural Anesthesia Tray, PERIFIX FX Continuous Epidural Tray, PERIFIX One Continuous Epidural Pediatric Tray; Utilization of Product: Injection of local anesthetics to provide regional anesthesia for pain management. Route of administration is injection into subarachnoid space or epidural space or tissue surrounding peripheral nerve bundle(s). Custom Epidural and Anesthesia Tray. Reason: There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue may cause the integrity of the sterile barrier to be compromised. A compromised sterile barrier poses a risk of inflammatory response and/or possible contamination of the spinal fluid or epidural space..

Recalling firm

B. Braun Medical, Inc.

Classification

Class II

Status

Terminated

Initiated

2015-03-27

Terminated

2017-02-01

Firm location

Allentown, PA, United States

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