Quick Facts at a Glance
- Recall Date
- September 18, 2025
- Hazard Level
- HIGH
- Brand
- B Braun Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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 tray with Tuohy needle and open-tip catheter
- Model numbers
- CE17TKF, REF: 332086, UDI-DI 04046955900985, Unit of Use 04046955900992, Lot 0062011669
- Sold at
- Unknown
- 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 tray is a medical device used in continuous epidural anesthesia. It includes a Tuohy needle and an open-tip catheter for placement and infusion during procedures.
Why This Is Dangerous
A lid misposition on the catheter connector can compromise the integrity of the connection, potentially affecting sterile barriers and flow pathways.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals may need to stop using affected kits and replace them. No injuries have been reported so far, but rapid action is required to avoid potential complications.
Practical Guidance
How to identify if yours is affected
- Check device label CE17TKF
- Verify Product Code CE17TKF
- Check UDI primary 04046955900985
- Check UDI unit 04046955900992
- Check Lot Number 0062011669
- If any mismatch, do not use the device
Where to find product info
On product labeling and the FDA recall page for Z-0117-2026.
What timeline to expect
Refunds or replacements may take several weeks after submission.
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- Escalate to hospital procurement or applicable regulatory bodies if needed
- Consider filing a report with CPSC if consumer-level devices are involved
How to prevent similar issues
- Verify recalls before using or purchasing epidural trays.
- Check UDIs and lot numbers regularly when receiving medical devices.
- Coordinate with suppliers to ensure recalled items are removed from distribution.
- education for clinical staff on recall processes.
Documentation advice
Keep recall notification, photos of labels and packaging, record product code CE17TKF, UDIs, lot numbers, and all correspondence.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model numbers: CE17TKF, REF: 332086. UDI-DI (Primary): 04046955900985. UDI-DI (Unit of Use): 04046955900992. Lot Number: 0062011669. 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. Quantity: 0 units. Product Code: CE17TKF. Seller/Manufacturer: B Braun Medical Inc. Sold at: Not specified. Recall Date: 2025-09-18. Status: ACTIVE. Classification: Class II.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Brand: B Braun Medical
- Product: PERIFIX FX Continuous Epidural Anesthesia Tray with CE17TKF
- Model numbers: CE17TKF; REF 332086
- UDI-DI (Unit of Use): 04046955900992
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.