The Recall Desk
HighFDA (Devices)·Z-3379-2018·Announced 2018-10-10

B. Braun Perifix One Epidural Full Tray Recall for Connector Issues

B. Braun Medical is recalling Perifix One Epidural Full Trays because the catheter connectors may not stay closed, leading to leakage or disconnection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (leakage/disconnection) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

B. Braun Medical, Inc. is recalling the CE18TKO Perifix One Epidural Full Tray, Material Number 332282. This connection device is used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for the delivery of anesthetics. The connector is used in conjunction with the catheter for the continuous administration of anesthetic fluids.

The recall is being issued because the catheter connectors may not stay closed during use. In some cases, leakage or disconnection of the catheters from the catheter connectors has been observed. The affected units are distributed worldwide, including the United States (nationwide), Australia, Canada, Guatemala, and Kuwait. The specific batch numbers involved are 61588931, 61589445, 61592524, 61609149, 61598518, 61615365, 61619575, and 61620760.

Healthcare providers and facilities should stop using the affected Perifix One Epidural Full Trays and contact B. Braun Medical, Inc. for instructions on how to return the product or obtain a replacement.

The recalled product

Product
CE18TKO PERIFIX ONE EPIDURAL FULL TRAY, Material Number 332282 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
Manufacturer
B. Braun Medical, Inc.
Category
Medical Device — Anesthesia / Catheter
Hazard
Affected units
22,280

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Batch: 61588931
  • 61589445
  • 61592524
  • 61609149
  • 61598518
  • 61615365
  • 61619575
  • 61620760

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 93 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 93 products in this recall →

Related recalls

Same manufacturer · B. Braun Medical, Inc.

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Same hazard · leakage

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