Class II U.S. Food and Drug Administration

B Braun Medical Inc Perifix FX Continuous Epidural Anesthesia Tray recall: Potential for the lid of the catheter connector to be in the incorrect

Recall published 1+ years ago

Potential for the lid of the catheter connector to be in the incorrect position.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Potential for the lid of the catheter connector to be in the incorrect position.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0119-2026
Published
October 15, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
B Braun Medical Inc
Product type
Medical devices
Units affected
21,270 units
Distribution
Nationwide
Made in
United States
Lot / code info
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. Expiration Date: 07/31/2026.
UPC codes
04046955899470, 04046955899487

Products covered by this recall

PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCS. Product Description: CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF.

Check your product

The notice names 14 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 04046955899470
  • 04046955899487

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 0062013051
  • 0062010532
  • 0062010533
  • 0062010534
  • 0062010535
  • 0062010536

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 07
  • 31
  • 2026. — 21
  • 270 units

Model or item number

On the rating label, the box or the instruction sheet.

  • 332097
  • CE17TKFCS

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

B Braun Medical Inc — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: B BRAUN MEDICAL INC — 861 Marcon Blvd, Allentown, PA, 18109-9577

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was B Braun Medical Inc medical devices recalled?

Potential for the lid of the catheter connector to be in the incorrect position. Potential for the lid of the catheter connector to be in the incorrect position.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 04046955899470, 04046955899487; lot code 0062013051, 0062010532, 0062010533; best-by date 07 or 31; model number 332097, CE17TKFCS. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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