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, 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 with Tuohy Needle and Catheter
- Model numbers
- CE17TBFC, REF: 332077, UDI-DI Primary 4046964177187, UDI-DI Unit of Use 4046964177170
- Sizes
- 17 Ga x 3-1/2 in. (9 cm) Tuohy needle, 19 Ga closed-tip catheter
- 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 system is used for continuous epidural anesthesia in clinical settings. It includes a Tuohy needle and a springwound catheter for pain management.
Why This Is Dangerous
A lid in the catheter connector that is not correctly positioned could affect the seal and flow, potentially compromising sterile barrier and delivery.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Direct medical procedure impact. Potential delays or complications in anesthesia delivery if used.
Practical Guidance
How to identify if yours is affected
- Check if your device corresponds to CE17TBFC with REF 332077 and UDI numbers 4046964177187 and 4046964177170.
- Inspect lot 0062022053 and expiration 10/16/2024.
- Confirm recall notification from B Braun Medical.
Where to find product info
FDA recall page Z-0114-2026 and manufacturer communications.
What timeline to expect
Refunds or replacements will be arranged via mailed recall communications; process timelines vary by facility.
If the manufacturer is unresponsive
- Document all communications with the hospital or supplier.
- Escalate to hospital compliance department or state health authority if the vendor is unresponsive.
How to prevent similar issues
- Verify LIDS and connectors during installation checks.
- Use only fresh, non-expired supplies; verify packaging integrity.
- Follow standard aseptic technique and supplier recall guidance when substituting products.
Documentation advice
Keep recall notices, lot numbers, UDI, and correspondence; photograph the device and packaging.
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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 PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Model codes: REF: 332077; UDI-DI Primary 4046964177187; UDI-DI Unit of Use 4046964177170. Sold/Distributed: Nationwide distribution 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. Recall Date: 2025-09-18. Report Date: 2025-10-15. Hazard: Potential for the lid of a
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- HIGH hazard level
- Lid position defect in catheter connector
- Single lot: 0062022053, Expiration 10/16/2024
- Unit of Use 4046964177170
- Product Code CE17TBFC
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