Recall MonitorHealth Products
Rifton TRAM and E-Pacer
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Community Products, Llc Dba Rifton Equipment
Issue: Medical devices - Performance
What to do: Field correction involves installing a body support upgrade kit.
Audience: General public
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| TRAM | More than 10 numbers, contact manufacturer. | K320 |
| TRAM | More than 10 numbers, contact manufacturer. | K310 |
| E-Pacer | More than 10 numbers, contact manufacturer. | K660 |
Issue
Rifton initiated recalls for TRAM and E-Pacer units due to an unrelated buckle spring failure, which led to replacing the full body support strap assembly. for that recall, rifton ordered a large batch of aluminum stampings (DA53). Because of the unusually large order, the supplier used a different manufacturing process, resulting in some stampings having sharper strap openings. over time, these sharp edges can abrade and fray the straps, and if not addressed, may cause the strap to fail, creating a fall risk for the user.