—#205797

Product

Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices intended for the administration of an analgesic or anesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathecal anesthesia. Product Code: 332248

FDA product code: OGE — Epidural Anesthesia Kit
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: UDI: 04046964178689 Lot Number: 0061855122 Exp. Date: 25.OCT.2024

Why it was recalled

Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.

Root cause (FDA determination)

Process control

Action the firm took

B.Braun issued Urgent Medical Device Recall letter on Monday, January 22, 2024. Letter states reason for recall, health risk and action to take: 1. Review the Device Recall Notification and ensure that all users of the product in your organization, and other concerned personnel are informed about this recall. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The recall is to be extended to the user level. 2. Determine your current inventory of the affected batches within inventory of your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Record the total number of individual impacted units on the Recall Acknowledgement Form. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Recall Acknowledgement Form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we receive your Recall Acknowledgement Form, a B. Braun Customer Support representative will contact you with instructions on how to return any impacted cases, including partial cases, in your possession and provide credit and/or replacement of the product based on your individual needs.

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: US Nationwide

Timeline

Recall initiated: 2024-01-22
Posted by FDA: 2024-02-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205797. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.