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, 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 tray with Tuohy needle and catheter
- Model numbers
- CE17TKFC, REF: 332079, 0062010541, 0062010542, 0062010543, 0062010545, 0062010546, 0062010547 +10 more
- 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 Continuous Epidural Anesthesia Tray includes a Tuohy needle and a closed-tip epidural catheter used in anesthesia. Hospitals and surgical centers acquire these trays for neuraxial anesthesia procedures.
Why This Is Dangerous
A mispositioned lid on the catheter connector can compromise the integrity of the connection, potentially affecting drug delivery or safety during use.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must verify device identifiers and ensure any recalled units are removed from use to prevent potential procedure-related complications.
Practical Guidance
How to identify if yours is affected
- Check model CE17TKFC and REF 332079 on the device label.
- Match UDI Primary 04046955899456 or Unit of Use 04046955899463 to the recall list.
Where to find product info
Recall notices are posted on the FDA enforcement page and the manufacturer’s recall communications.
What timeline to expect
Remedial steps for hospitals follow internal procurement and vendor processes. Individual refund or replacement timelines vary by facility.
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer.
- Escalate to FDA recall contacts if the supplier is nonresponsive.
- Keep all correspondence for records.
How to prevent similar issues
- Verify connector lid position before use when applicable.
- Review future shipments for proper labeling and lid integrity.
- Ask suppliers for device-specific incident reports and recall history prior to purchase.
Documentation advice
Keep the recall letter, correspondences with the manufacturer, model numbers, UDI codes, and lot numbers for future reference.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Nationwide distribution to multiple states
- Hazard: lid misalignment in catheter connector
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.