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Recall Observatory FDA recall evidence

Device product

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

Z-1351-2019

February 04, 2019

Class II

Product summary

Firm
Moller Vital
Event
Event 81977
Status
Ongoing
Classification
Class II
Quantity
427 total
Official record key
device-enforcement:Z-1351-2019

Official wording

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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.