B. Braun Medical Recalls Pain Control Trays Due to Sterile Barrier Risk
B. Braun Medical is recalling specific pain control trays because a potential hole in the outer tray may compromise the sterile barrier, posing a risk of contamination.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (contamination/inflammatory response) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
B. Braun Medical, Inc. is recalling approximately 5,000 units of various pain control trays, including CONTIPLEX, Custom Epidural, and PERIFIX models. The recall is due to a potential hole in the outer tray of a limited number of these products. This defect may compromise the integrity of the sterile barrier.
A compromised sterile barrier poses a risk of inflammatory response and possible contamination of the spinal fluid or epidural space. The affected products are used for the injection of local anesthetics to provide regional anesthesia for pain management.
The recalled trays were distributed nationwide. Consumers and healthcare providers should stop using the affected trays and contact B. Braun Medical for further instructions.
The recalled product
- 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…
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 5,000
Distribution
Distributed nationwide across the United States.
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