Class II U.S. Food and Drug Administration

B Braun Medical Inc Perifix FX Continuous Epidural Anesthesia Tray with Perifix 17 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

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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-0116-2026
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
48,110 units
Distribution
Nationwide
Made in
United States
Lot / code info
REF: 332079; Product Code: CE17TKFC; UDI-DI (Primary): 04046955899456; UDI-DI (Unit of Use): 04046955899463; Lot Numbers: 0062010541, 0062010542, 0062010543, 0062010545, 0062010546, 0062010547, 0062010548, 0062010549, 0062010550, 0062010743, 0062013041, 0062013042, 0062013043, 0062013044, 0062013045, 0062013046, 0062013047, 0062013049, 0062015114, 0062015113, 0062015112, 0062015110. Expiration Date: 07/31/2026.
UPC codes
04046955899456, 04046955899463

Products covered by this recall

PERIFIX FX Continuous Epidural Anesthesia Tray with 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: CE17TKFC. Product Description: CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY.

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.

  • 04046955899456
  • 04046955899463

Lot or batch code

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

  • 0062010541
  • 0062010542
  • 0062010543
  • 0062010545
  • 0062010546
  • 0062010547

Best-by / use-by date

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

  • 07
  • 31
  • 2026. — 48
  • 110 units

Model or item number

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

  • 332079
  • CE17TKFC

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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 04046955899456, 04046955899463; lot code 0062010541, 0062010542, 0062010543; best-by date 07 or 31; model number 332079, CE17TKFC. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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