Quick Facts at a Glance
- Recall Date
- September 18, 2025
- Hazard Level
- HIGH
- Brand
- B BRAUN MEDICAL
- Category
- Health & Personal Care
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, 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 and catheter set
- Model numbers
- CE17TKFCPS, REF: 332078
- 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
This is a sterile medical device used for continuous epidural anesthesia. It includes an epidural needle and catheter within a tray setup for clinical use.
Why This Is Dangerous
A lid misalignment could compromise catheter connector integrity, potentially impacting sterile connection and delivery.
Industry Context
This recall is not described as part of a broader industry-wide pattern in the provided data.
Real-World Impact
Immediate discontinuation of use is required. No injuries reported yet, but potential for device malfunction requires medical oversight.
Practical Guidance
How to identify if yours is affected
- Verify product code CE17TKFCPS
- Confirm UDI primary 04046955899432
- Check Unit of Use 04046955899449
Where to find product info
Identifier labels are on the tray and packaging; UDI and lot numbers are printed on the labeling and unit packaging.
What timeline to expect
Refunds or replacements follow manufacturer instructions via notification letters; timelines not specified.
If the manufacturer is unresponsive
- Escalate to hospital procurement or device representative
- File a formal complaint with the FDA if needed
How to prevent similar issues
- Verify device labeling matches recall information before use
- Store affected lots separately and quarantine unused units
- Follow standard sterile processing and device recall protocols
Documentation advice
Keep recall notices, product packaging, lot numbers, and correspondence with supplier.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Brand: B BRAUN MEDICAL. Product: PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. Tuohy Epidural Needle Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code CE17TKFCPS. Model references include REF: 332078, UDI-DI primary 04046955899432 and Unit of Use 04046955899449. Lot numbers include 0062006314, 0062011670, 0062028428. Distribution: Nationwide across 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.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- HIGH hazard level
- Class II device
- Active recall as of 2025-10-15
- Product Code CE17TKFCPS
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.