Prism Medical Carry Bar Recall Due to Breaking Plastic Component
Prism Medical is recalling carry bars for patient lifts because a black plastic puck may break, posing a risk of harm to patients.
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 is classified as FDA Class II and involves a risk-of-harm product where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
ErgoSafe Products, LLC (DBA Prism Medical) is recalling carry bars, which are accessories used with patient lifts in hospitals and other facilities. The recall affects model numbers 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757. The total quantity involved is not greater than 17,964 units.
The recall is being conducted because the black plastic puck on the carry bar is breaking, which creates a potential for patient harm. The FDA has classified this as a Class II recall.
The affected units were distributed in the United States, Canada, Japan, Australia, Thailand, Great Britain, and South Korea. There are no lot numbers, serial numbers, or UPC codes to identify the units; only the model numbers are available for identification.
The recalled product
- Product
- Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.
- Manufacturer
- ErgoSafe Products, LLC (DBA) Prism Medical
- Affected units
- 17,964
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 (10)
- There are no lot numbers
- serial numbers
- or UPC codes
- only the model numbers. Model numbers: 360741
- 360750
- 360751
- 360755
- 360755 Rev B
- 360756
- and 360757.
Distribution
Distributed nationwide across the United States.
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