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Terminated

PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

FDA Recall Z-0013-2018 · Posted 2017-09-15

Recalling FirmHandicare Usa Inc
Recall StatusTerminated
Product CodeFSA
Date Initiated2017-09-08
Date Terminated2018-12-17
Product Quantity8 units

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.

Firm Action

The firm initiated their recall by email on 09/08/2017. The consignee was warned that the lift straps may wear prematurely and they would be contacted by a representative and the units would be replaced.

Root Cause

Component design/selection

Distribution Pattern

Us and Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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