FDA Device Recall Z-0013-2018: Handicare Usa Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0013-2018.

Recall Res Number

Z-0013-2018

Recalling Firm / Manufacturer

Handicare Usa Inc

FEI Number

3007802293

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2017-09-08

Date Posted

2017-09-15

Date Terminated

2018-12-17

Product Code

FSA

Event Number

78096

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.

Action Details 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.

Distribution Pattern Us and Canada

Code Information / Serial Numbers A6M0001526, A6M0001527, A6M0001528, A6M0001529, A6M0001530, A6M0001485, A6M0001486, A6M0001498

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Medical Device Recall: Z-0013-2018

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer