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, 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 Tray and Catheter
- Model numbers
- CE17TKFS, REF: 332098, UDI-DI 04046955901067, UDI-DI Unit of Use 04046955901074
- 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
This is a medical device used in anesthesia administration during procedures requiring epidural analgesia. It is distributed nationwide to healthcare facilities.
Why This Is Dangerous
A lid misalignment can affect catheter connection integrity and potentially impact drug delivery during anesthesia.
Industry Context
This recall is not identified as part of a broader industry pattern.
Real-World Impact
The immediate impact is restricted to clinical use and may affect procedural safety until devices are replaced or corrected.
Practical Guidance
How to identify if yours is affected
- Identify product CE17TKFS with REF: 332098 and UDI 04046955901067/04046955901074.
- Check lot numbers: 00620096222, 0062014350.
- Review distribution list for AK-ND etc. (nationwide).
Where to find product info
FDA enforcement page Z-0120-2026 provides recall details.
What timeline to expect
Recall processing timelines vary; follow manufacturer guidance via letter.
If the manufacturer is unresponsive
- Document all communications
- Contact FDA if manufacturer fails to provide remedy
- Request escalation through hospital risk management
How to prevent similar issues
- Verify lid alignment during setup of similar epidural systems in the future
- Consult official device labeling and hospital procurement for CE marking compliance
- Maintain updated SOPs for device verification at point of care
Documentation advice
Keep recall letter, device labels, UDI numbers, lot numbers, and correspondence with manufacturers.
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Product Details
Brand: B BRAUN MEDICAL. Product: PERIFIX FX Continuous Epidural Anesthesia Tray and PERIFIX 17 Ga. x 3-1/2 in. Tuohy Epidural Needle Winged; 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Model/Code: CE17TKFS. REF: 332098. UDI-DI (Primary): 04046955901067. UDI-DI (Unit of Use): 04046955901074. Lot Numbers: 00620096222, 0062014350. Product Code: CE17TKFS. 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.
Reported Incidents
No specific injuries or incidents are cited in the recall notice.
Key Facts
- 2,760 total units recalled
- Class II device
- Hazard level: HIGH
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Safety Guide
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