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 kit with Tuohy needle and catheter
- Model numbers
- Product Code CE17TKFSDT, REF 332093, UDI-DI Primary 04046964954252, UDI-DI Unit of Use 04046964954245, Lot 0062003112
- Sizes
- 17 Ga x 3-1/2 in Tuohy Epidural Needle - Fixed Wings, 19 Ga Open Tip Epidural 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 CE17TKFSDT is an epidural anesthesia tray intended for clinical use. It includes a 17 Ga Tuohy needle with fixed wings and a 19 Ga Open Tip Epidural Catheter. Healthcare settings use these components together during neuraxial anesthesia.
Why This Is Dangerous
If the catheter connector lid is not in the correct position, the connection may not seal properly or may misalign during use, potentially affecting catheter performance.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
In clinical settings, any lid misposition could compromise catheter integrity, potentially impacting anesthesia administration and patient safety. Hospitals should identify affected lots and replace or repair as directed.
Practical Guidance
How to identify if yours is affected
- Check Product Code CE17TKFSDT on the device label
- Check UDI-DI Primary 04046964954252
- Check UDI-DI Unit of Use 04046964954245
- Validate Lot Number 0062003112
Where to find product info
Details are available on the FDA recall enforcement page for Z-0118-2026 and through the manufacturer’s recall communications.
What timeline to expect
Manufacturers generally complete replacements or refunds within weeks to months depending on facility and stock.
If the manufacturer is unresponsive
- Escalate to hospital compliance officer
- File a report with FDA MedWatch if warranted
- Seek guidance from regulatory affairs
- Consider alternate supplier communications and documented responses
How to prevent similar issues
- Maintain an up-to-date log of device recalls
- Verify UDI numbers for all epidural trays before use
- Coordinate with procurement on replacement units
- Establish a recall response protocol in the operating room
Documentation advice
Keep copy of recall notice, the lot number, and correspondence with the manufacturer. Document any replacements or instructions given by clinicians.
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Product Details
Product: PERIFIX FX Continuous Epidural Anesthesia Tray with 17 Ga Tuohy Needle (3-1/2 in) fixed wings and 19 Ga Open Tip Epidural Catheter. Product Code: CE17TKFSDT. REF: 332093. UDI-DI Primary: 04046964954252. UDI-DI Unit of Use: 04046964954245. Lot Number: 0062003112. Sold 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. Distributor: B Braun Medical. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Nationwide distribution with listed state coverage
- Product Code CE17TKFSDT
- UDI unit of use 04046964954245
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Safety Guide
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