Perifix recallZ-2627-2023 · B. Braun Medical, Inc. · initiated Jul 31, 2023
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
Product may be mislabeled with an incorrect lid stock label.
FDA root cause category: Process control
What the company is doing
An "URGENT MEDICAL DEVICE RECALL" letter dated 8/14/23 was issued to affected customers on 08/14/2023. The letter described the product, problem and actions to be taken. The Customers are instructed to review inventory, cease use and quarantine impacted product and complete and return the Product Recall Acknowledgement Form back to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610)849-1197 or email to [email protected]. B. Braun Medical will facilitate return of impacted product. If you have any questions, contact BBMI's Postmarket Surveillance Department at 1-833-425-1464.
Recall details
- Recall number
- Z-2627-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 31, 2023
- Posted by the FDA
- Sep 21, 2023
- Recalling firm
- B. Braun Medical, Inc.
- Quantity
- 3440 units
- Product code
- OGE
- Distribution
- US Distributions to states of - AR, AZ, CA, FL, GA, IL, MA, MO, NC, NJ, PA, TX, WA
Product description
Perifix / Epidural anesthesia set, medicated
Code information (models, lots, serial numbers)
UDI-DI: 04046964178726 Product Code: 332250; Lot Number 0061863524, expiration date 30.APR.2025
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Perifix® 332250B. Braun Medical Inc. · Epidural anesthesia kit1 recall1 report
Product lines
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.
How recalls are matched to devices · Editorial policy · Report an error on this page