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U.S. Department of Health and Human Services

Class 2 Device Recall B.Braun

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  Class 2 Device Recall B.Braun see related information
Date Initiated by Firm January 22, 2024
Date Posted February 16, 2024
Recall Status1 Open3, Classified
Recall Number Z-1150-2024
Recall Event ID 93889
Product Classification Epidural anesthesia kit - Product Code OGE
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
Code Information UDI: 04046964178689 Lot Number: 0061855122 Exp. Date: 25.OCT.2024
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact SAME
610-596-0500
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 3,890 units
Distribution US Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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