Z-1351-2019Class II

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

Name: Z-1351-2019 Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021
Creator: Moller Vital
Published: 2019-02-04
License: https://open.fda.gov/license/

Etac A/S / initiated 2019-02-04 / Open, Classified

FDA source

Moller Vital began a recall of Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021 on 2019-02-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1351-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-02-04
Posted: 2019-05-16
Recalling firm: Etac A/S
Product: Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: 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.
FDA 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 in commerce: 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.
Product codes and lots: All units manufactured between May 2013 and October 2018. Date of manufacture is labeled on the product.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1351-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1351-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-22	2019-05-16
Z-1352-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-05-22	2019-05-16

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)