Four point sling bars recalled after a mounting bolt broke
ETAC A/S is recalling 25 Molift 4-point sling bars after a customer reported the bolt for mounting the lifting bar breaking during assembly and load testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record's stated consequence is limited joint mobility preventing proper functionality, with no patient harm or reported injury.
Plain-English summary
Molift 4-point sling bars, accessories to mobile hoists, model/catalog numbers 1430116, 1430117 and 1430115, are being recalled by ETAC A/S. The record describes the mobile hoist as an assistive device intended for alleviation of, or compensation for, a functional impairment due to an injury or disability.
The record states a customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. The record states such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
The record lists 25 units, with UDI-DI codes recorded as TBD in the enforcement record. Distribution was worldwide, covering the United States in the state of Pennsylvania and the countries listed in the record. The FDA has classified the action as Class II.
The stated consequence in the enforcement record is limited joint mobility preventing proper functionality, and no injuries are reported. Facilities and users should follow ETAC's instructions.
The recalled product
- Product
- Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to
- Manufacturer
- ETAC A/S
- Category
- Medical Device — Patient hoist
- Affected units
- 25
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- (1) Model/Catalog Number: 1430116
- UDI-DI: TBD
- (2) Model/Catalog Number: 1430117
- (3) Model/Catalog Number: 1430115
Distribution
Part of a larger recall action
This product is one of 4 recalled by ETAC A/S under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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