FDA Device Recall Z-0014-2018: Handicare AB Maskinvagen

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0014-2018.

Recall Res Number

Z-0014-2018

Recalling Firm / Manufacturer

Handicare AB Maskinvagen

FEI Number

3009481053

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2016-07-28

Date Posted

N/A

Date Terminated

2018-12-17

Product Code

FSA

Event Number

78130

Product Quantity

9 units

Product Description Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009

Reason for Recall A limited amount of Carina mobile lifts have been delivered with a too small locking pin. If a locking pin smaller than the correct size is mounted on the Carina mobile lift, the locking pin is likely to cause increased wear on the plastic bushings. In case of continued use, these components may cause wear on the metal of the piston rod eye.

Action Details The firm initiated their recall by email on 07/28/2017. The firm directed the consignee to repair the units on site and destroy the affected parts.

Distribution Pattern OH, PA, MD

Code Information / Serial Numbers a) Carina350EM, REF 6060011, Serial numbers: 661102000 - 661102160 b) Carina350EML, REF 60600012, Serial numbers: 661200500 - 661200584 c) Carina350EE, REF 60600009, Serial numbers: 660900500 -660900571

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Medical Device Recall: Z-0014-2018

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer