Recall record at a glance
| Official record | Z-0165-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Community Products, LLC |
| Report date | Oct 30, 2019 |
| Recall initiation date | Mar 21, 2019 |
| Quantity | 1079 |
| Location | Rifton, NY, United States |
Official product description
Rifton TRAM Low Base, SKU K320, powered lift device
Why the product was recalled
A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use.
Distribution information
The products were distributed US nationwide. The products were distributed to the following foreign countries: Foreign Countries: Worldwide, including Canada, United Kingdom, Germany, Japan, Singapore, South Korea, United Arab Emirates, Taiwan, Denmark, Italy, Hong Kong, Ireland, Australia, New Zealand, Israel, Colombia, Russia
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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