The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1473-2013·Announced 2013-06-12

Hill-Rom Recalls SlingBar 350 Patient Lifting Devices Due to Impalement Risk

Hill-Rom is recalling 3,556 SlingBar 350 patient lifting devices because a retrospective review found four units may present a potential for impalement if a person falls onto the hooks.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 risk-of-harm product (impalement) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Hill-Rom, Inc. is recalling 3,556 SlingBar 350 patient lifting devices. The SlingBar 350 is designed to meet the needs for lifting humans. The recall was initiated after a retrospective review found that four sling bars may present a potential for impalement if a patient, caregiver, or bystander were to fall onto the hooks, based on a simulated test method.

The affected products were distributed worldwide, including nationwide in the United States and in Canada, Australia, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Netherlands, Norway, New Zealand, Portugal, Sweden, and Turkey. The specific product codes involved are 3156015, 3156002, 3156008, and 3156004.

In an effort to eliminate any risk of injury, Hill-Rom is requesting that the products be removed from field use and replaced with an updated design.

The recalled product

Product
SlingBar 350. Designed to meet the needs for lifting humans.
Manufacturer
Hill-Rom, Inc.
Category
Medical Device — Patient Lifting Equipment
Hazard
Affected units
3,556

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 (3)

  • 3156015
  • 3156002
  • 3156008' 3156004

Distribution

Distributed nationwide across the United States.

The notice also names 24 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Hill-Rom, 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 4 products in this recall →

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