ArjoHuntleigh Recalls Spreader Bars for Ceiling Lifts Due to Hook Flexibility
Arjo, Inc. is recalling 363 spreader bars for the Maxi Sky 2 Ceiling Lift because the hooks are too flexible to securely hold sling loops.
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 medical device with a mechanical defect that could lead to patient falls or injury, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Arjo, Inc. dba ArjoHuntleigh is recalling 363 Medium 2-Hooks Spreader Bars (Model 700-19425) used with the Maxi Sky 2 Ceiling Lift. These devices are intended for general patient transfers in hospital settings. The recall covers spreader bars distributed in Arkansas, Georgia, Michigan, Pennsylvania, and the District of Columbia.
The recall was initiated because the upper portion of the hooks on the spreader bars is too flexible to securely hold the loops of the sling. If a sling loop is positioned in the upper portion of the hooks, it could potentially come out, posing a risk of patient falls or injury during transfers.
Hospitals and healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. If the affected spreader bars are found, they should be removed from service and returned to Arjo, Inc. for inspection or replacement.
The recalled product
- Product
- Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. Intended to be used for general transfers in hospitals.
- Manufacturer
- Arjo, Inc. dba ArjoHuntleigh
- Category
- Medical Device — Patient Lifts
- Affected units
- 363
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 (20)
- Serial numbers 1942500017
- 1942500025
- 1942500030
- 1942500053
- 1942500054
- 1942500055
- 1942500056
- 1942500057
- 1942500058
- 1942500059
- 1942500060
- 1942500061
- 1942500062
- 1942500063
- 1942500064
- 1942500065
- 1942500066
- 1942500067
- 1942500068
- 1942500069
Distribution
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