Z-0013-2018 Class II Terminated
FDA device recall Z-0013-2018 was initiated by Handicare Usa Inc on September 8, 2017 and is designated Class II. Reason for recall: During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625 l… The recall status is terminated (terminated December 17, 2018). Affected quantity: 8 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 18, 2017
- Initiation Date
- September 8, 2017
- Termination Date
- December 17, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 units
Product Description
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Reason for Recall
During internal cycle testing of A-Series lifts Handicare has found that the A-Series lift strap for lifts manufactured between April 25, 2017 and June 12, 2017 may wear prematurely at max load (625 lbs). We have identified the root cause as a supplied component that was not to specification. If the strap wears during use there is a potential risk for the person being supported by the lift to drop.
Distribution Pattern
Us and Canada
Code Information
A6M0001526, A6M0001527, A6M0001528, A6M0001529, A6M0001530, A6M0001485, A6M0001486, A6M0001498