Quick Facts at a Glance
- Recall Date
- September 18, 2025
- Hazard Level
- HIGH
- Brand
- B Braun Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- B Braun Medical
- Product type
- Epidural anesthesia set with Tuohy needle and catheter
- Model numbers
- CE17TFC, REF: 332238, 04046964178603, 04046964178597, 0062014626
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 18, 2025
Reported by FDA DEVICE
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for the lid of the catheter connector to be in the incorrect position.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B BRAUN MEDICAL INC or your healthcare provider for instructions. Notification method: Letter
About This Product
The PERIFIX FX Continuous Epidural Anesthesia Set is used for delivering epidural anesthesia during procedures. It includes a Tuohy needle and a catheter assembly designed for sterile, single-use clinical use.
Why This Is Dangerous
A lid-position defect in the catheter connector could compromise connection integrity and delivery of anesthetic agents, posing safety risks during procedures.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
For patients undergoing epidural anesthesia, a mispositioned connector lid could affect drug delivery and patient safety. Healthcare facilities must halt use until instructed otherwise.
Practical Guidance
How to identify if yours is affected
- Identify the CE17TFC product code and REF 332238 in inventory
- Check UDI-DI numbers 04046964178603 (primary) and 04046964178597 (unit of use)
- Verify Lot number 0062014626 on the device packaging or accompanying documentation
Where to find product info
Recall notification letters and the FDA enforcement page provide official guidance and contact details.
What timeline to expect
Manufacturer guidance will specify replacement or remedy timelines; no specific window is provided in the recall notice.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer
- Escalate to hospital risk management or patient safety officers
- Contact FDA recall assistance if the manufacturer remains unresponsive
How to prevent similar issues
- Audit inventory for CE17TFC and CE17TFC-related components
- Coordinate with procurement to source only recalled-safe devices
- Implement standard recall alert procedures within clinical procurement
- Verify lid-position integrity during device setup to identify obvious defects early
Documentation advice
Keep recall letters and correspondence, preserve affected product batches, photograph labels and serial numbers, maintain propersale and purchase records for potential reimbursement
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Product Details
Model numbers and identifiers: CE17TFC; REF 332238; UDI-DI (Primary) 04046964178603; UDI-DI (Unit of Use) 04046964178597; Lot Number 0062014626. Distribution: Nationwide to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Sold through healthcare channels; no consumer device retail listing provided. Recall date: 2025-09-18. Status: ACTIVE. Remedy: Stop using the device immediately and follow recall instructions. Supplier: B Braun Medical Inc.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- CE17TFC is the product code for the affected set
- Lot 0062014626 identified in the recall
- Nationwide distribution across many states; no consumer retailer list provided
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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