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
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 epidural catheter
- Model numbers
- CE17TKFCS, REF: 332097, UDI-DI Primary 04046955899470, UDI-DI Unit of Use 04046955899487
- 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 Continuous Epidural Anesthesia Tray is used in surgical settings to administer epidural anesthesia via a Tuohy needle and associated catheter. It is distributed to healthcare facilities nationwide.
Why This Is Dangerous
A potential misalignment of the catheter connector lid could compromise the integrity of the connection, potentially affecting safety during epidural administration.
Industry Context
This recall is not indicated as part of a broader industry pattern in the provided data.
Real-World Impact
Clinicians must verify device integrity before use. The issue prompts immediate removal from service to protect patients during anesthesia and may cause operational delays in procedures.
Practical Guidance
How to identify if yours is affected
- Cross-check product code CE17TKFCS and REF: 332097 against inventory.
- Inspect UDI-DI codes: 04046955899470 (Primary) and 04046955899487 (Unit of Use).
Where to find product info
FDA recall page and manufacturer recall notice for instructions and disposition of units.
What timeline to expect
Refunds or replacements, if applicable, typically follow the manufacturer's timeline in 4-8 weeks depending on disposition and facility processing.
If the manufacturer is unresponsive
- Escalate to hospital procurement leadership and document all communications.
- File complaints with the FDA if the manufacturer is unresponsive.
How to prevent similar issues
- Verify connector lid assemblies before use in any epidural tray purchases.
- Request manufacturer confirmation of lid-position stability before use in clinical settings.
- Keep recalls documented and segregate affected devices until disposition.
Documentation advice
Keep a log of lot numbers checked, actions taken, communications with the manufacturer, and any refunds or replacements processed.
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Product Details
Model numbers and identifiers: REF: 332097; Product Code: CE17TKFCS; UDI-DI Primary: 04046955899470; UDI-DI Unit of Use: 04046955899487; Lot Numbers: 0062013051, 0062010532, 0062010533, 0062010534, 0062010535, 0062010536, 0062010555, 0062013050, 0062013053, 0062013052. 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. Sold since: Unknown. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product: PERIFIX FX Continuous Epidural Anesthesia Tray with 17G Tuohy needle and 19G closed-tip EPi
- CAS / Product Code: CE17TKFCS
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Safety Guide
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