Handicare A-Series Patient Lifts Recalled for Premature Strap Wear
Handicare is recalling 8 A-Series patient lifts because the lift straps may wear prematurely at maximum load, posing a risk of patient drop.
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 (patient drop) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Handicare USA Inc. is recalling 8 units of the PRISM MEDICAL A-625 patient lift (non-A/C powered, max load 625 lbs). The recall affects units manufactured between April 25, 2017, and June 12, 2017, which were distributed in the US and Canada.
During internal cycle testing, Handicare identified that the A-Series lift strap may wear prematurely when used at the maximum load of 625 lbs. The root cause was determined to be a supplied component that did not meet specifications. If the strap wears during use, there is a potential risk that the person being supported by the lift could drop.
Affected units have serial numbers A6M0001526, A6M0001527, A6M0001528, A6M0001529, A6M0001530, A6M0001485, A6M0001486, and A6M0001498. Users should check their serial numbers and contact Handicare for further instructions.
The recalled product
- Product
- PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
- Manufacturer
- Handicare Usa Inc
- Category
- Medical Device — Patient Lifts
- Affected units
- 8
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)
- A6M0001526
- A6M0001527
- A6M0001528
- A6M0001529
- A6M0001530
- A6M0001485
- A6M0001486
- A6M0001498
Distribution
Distribution scope not specified by the agency.
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