Perifix recallZ-1149-2024 · B. Braun Medical, Inc. · initiated Jan 22, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from B. Braun Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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 [email protected] 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.
Recall details
- Recall number
- Z-1149-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 22, 2024
- Posted by the FDA
- Feb 16, 2024
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 3,480 units
- Product code
- OGE
- Distribution
- US Nationwide
Product description
Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. Springwound Closed Tip Catheter, 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. Product Code: 332079
Code information (models, lots, serial numbers)
UDI: 04046964177224 Lot Number: 0061855319 Exp. Date: 30.APR.2024
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Perifix® 332079B. Braun Medical Inc. · Epidural anesthesia kit1 recall45 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93889).
- Z-1150-2024 · Open, ClassifiedEpidural 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 anesthet…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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