Moller Vital: Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021

Recall number

Z-1351-2019

Recalling firm

Moller Vital

Product

Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021

Status

Open, Classified

Initiated

2019-02-04

Posted

not on file

Terminated

not on file

Reason

The firm has received 7 reports of malfunction for the device in which the hooks have broken off, potentially leading the sling to slip out of the sling bar and causing the patient to fall.

Root cause

Use error

Action

On February 4, 2019, the firm notified customers of the recall via Urgent Field Safety Notice letter. The letter alerted customers to the recalled product. The firm stated that all new 2-Point Sling Bars are now equipped with metal alloy hooks instead of the previously used composite hooks. As part of this recall, the firm will replace the recalled devices with the new design. Distributors were asked to do the following: 1) Read the instructions, and complete and return the customer response form 2) Notify affected customers of the recall 3) Review the list of sales records from Etac Supply Gjvik and supply additional information from your records. 4) Identify and contact end-customers/users and decide the requirement for ordering new units 5) Order new 2-Point Sling Bars from Etac Supply Gjvik 6) Ship replacement units to end customers accompanied by replacement instructions (see user manual) and the Consignee Form. The End-User/Customer must perform the replacement and fill the replacement records (green fields) in the consignee form and return a signed copy to the distributor. 7) Receive the signed Consignee Form from end-users/customers. Perform weekly reporting to Etac Supply Gjvik in the same spreadsheet that contains the sales records. The signed Consignee Forms must be returned to Etac Supply Gjvik as a complete package upon finalizing all replacements.

Quantity

427 total

Distribution

Domestic distribution to Arizona, Delaware, Florida, Georgia, Massachusetts, Ohio, South Carolina, Texas, Washington, and Wisconsin. Foreign distribution to Canada, Asia, Europe, and Australia.

Lot, serial or model codes

All units manufactured between May 2013 and October 2018. Date of manufacture is labeled on the product.

510(k) numbers

not on file

PMA numbers

not on file

Product code

FSA

Firm FEI

3004137175

Firm city

Gjovik

Firm state

not on file

Firm country

Norway

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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