Recall Z-0013-2018— Handicare Usa Inc
Class II · Terminated
Class II FDA medical device recall by Handicare Usa Inc, initiated 2017-09-08, terminated 2018-12-17. FDA's recall record names no specific 510(k) clearance for this event. Product: PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered. Reason: 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..
- Recalling firm
- Handicare Usa Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-08
- Terminated
- 2018-12-17
- Firm location
- Maryland Heights, MO, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.