The Recall Desk
HighFDA (Devices)·Z-2671-2020·Announced 2020-07-29

Becton Dickinson Recalls SafeStep Huber Needle Sets Due to Tubing Cracks

Becton Dickinson is recalling SafeStep Huber Needle Sets because tubing may crack or break, potentially causing leakage of chemicals or biohazard materials.

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 defect that could lead to serious health consequences such as air embolism or infection, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Becton Dickinson & Company is recalling SafeStep Huber Needle Sets, including catalog numbers LH-0029 through LH-0040, due to a potential defect in the device tubing. The recall covers 5,296,132 units that were distributed worldwide.

The recall is being issued because the tubing near the Luer or Y site of the device may develop cracks or breaks. If the tubing breaks or cracks, it can cause leakage, resulting in exposure to chemicals such as chemotherapeutics or biohazard materials like blood.

A crack or break in the tubing could lead to potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection. Users should check their devices for the specific catalog and lot numbers listed in the official recall notice and contact Becton Dickinson for instructions on how to proceed.

The recalled product

Product
SafeStep Huber Needle Set; Catalog Numbers LH-0029 (UDI 00801741066160), LH-0030 (UDI 00801741066184), LH-0031 (UDI 00801741066207), LH-0032 (UDI 00801741066221), LH-0033 (UDI 00801741066245), LH-0034 (UDI 00801741066269), LH-0035 (UDI 00801741066283), LH-0036 (UDI 0080174106630
Affected units
5,296,132

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 (11)

  • Catalog Numbers LH-0029 (UDI 00801741066160)
  • LH-0030 (UDI 00801741066184)
  • LH-0031 (UDI 00801741066207)
  • LH-0032 (UDI 00801741066221)
  • LH-0033 (UDI 00801741066245)
  • LH-0034 (UDI 00801741066269)
  • LH-0035 (UDI 00801741066283)
  • LH-0036 (UDI 00801741066306)
  • LH-0037 (UDI 00801741066320)
  • LH-0038 (UDI 00801741066344)
  • LH-0039 (UDI 00801741066368)

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 12 recalled by Becton Dickinson & Company 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 12 products in this recall →