Z-1352-2019 Class II Ongoing
FDA device recall Z-1352-2019 was initiated by Moller Vital on February 4, 2019 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 427 (total).
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2019
- Initiation Date
- February 4, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 427 (total)
Product Description
Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003
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.
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.
Code Information
All units manufactured between May 2013 and October 2018. Date of manufacture is labeled on the product.