PlainRecordsFDA · Medical device recall
Craftmatic Model 1 Base for Dual Bed Configurations and 1 more product
- Date
- Aug. 10, 2022
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing
- Filed by
- Craftmatic Industries, Inc.
- Reason
- A potential for dual-configured beds to separate or slip away from one another.
- Distribution pattern
- US Nationwide distribution - product was not distributed outside of the United States
2 products in this recall
Craftmatic Model 1 Base for Dual Bed Configurations
- Product
- Craftmatic Model 1 Base for Dual Bed Configurations
- Quantity
- N/A
- Codes and lots
- 4AM663, 4AM669, 4AR391, 4AR445, 4AR797, 4AR790, 4AR795
- Recall started
- March 24, 2017
- Device type
- Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
- Root cause (FDA)
- Component design/selection
- What the company told customers
- The firm initiated the recall by email on 03/24/2017. The notice explained the issues and provided the following actions: "1. If your bed or beds is/are on a smooth surface or on carpeting that does not secure the position of the bed(s), we require that rubber castor cups be laced under the legs of the bed. 2. If you purchased a dual system (two beds side by side with two individual mattresses) and your beds are not connected so as to prevent separation, we will assist you in connecting them with our recommended strapping. Craftmatic will make appropriate arrangements to ensure that your dual system beds are properly connected or secured without cost to you. 3. If you no longer are in possession of the bed(s) you received form Craftmatic it is IMPORTANT that you provide Craftmatic with the contact information for the current user of the bed or beds. Likewise, if the bed has been discarded and is not available for use by anyone it is IMPORTANT that you inform Craftmatic. 4. It is IMPORTANT that Craftmatic receive confirmation that you have received this notification. To assist us in this regard please check or select one of the web links provided below. Selection the first option will automatically notify us that you have received ad read this notification. Selecting the second option will take you to a different webpage where you will be asked to answer a series of questions. That webpage will provide instruction for providing the required information. Proceed by selecting the Web Link Option 1 or 2 as applicable: 1. ___I received this notice and the information above does not apply. 2. ___I received this notice and will call in reference to the information above. Please Note: If your beds are installed with both rubberized castor cups and dual beds have been secured you must still notify us that you have received this notice and understand what is requested of you. RESOLUTION: Issue 1. If you require to be supplied with rubberized castor cups or need as
- Recall number
- Z-1499-2022
Legacy Base for Dual Bed Configurations
- Product
- Legacy Base for Dual Bed Configurations
- Quantity
- N/A
- Codes and lots
- 4AT056, 4AT061, 4AT063
- Recall started
- March 24, 2017
- Device type
- Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
- Root cause (FDA)
- Component design/selection
- What the company told customers
- The firm initiated the recall by email on 03/24/2017. The notice explained the issues and provided the following actions: "1. If your bed or beds is/are on a smooth surface or on carpeting that does not secure the position of the bed(s), we require that rubber castor cups be laced under the legs of the bed. 2. If you purchased a dual system (two beds side by side with two individual mattresses) and your beds are not connected so as to prevent separation, we will assist you in connecting them with our recommended strapping. Craftmatic will make appropriate arrangements to ensure that your dual system beds are properly connected or secured without cost to you. 3. If you no longer are in possession of the bed(s) you received form Craftmatic it is IMPORTANT that you provide Craftmatic with the contact information for the current user of the bed or beds. Likewise, if the bed has been discarded and is not available for use by anyone it is IMPORTANT that you inform Craftmatic. 4. It is IMPORTANT that Craftmatic receive confirmation that you have received this notification. To assist us in this regard please check or select one of the web links provided below. Selection the first option will automatically notify us that you have received ad read this notification. Selecting the second option will take you to a different webpage where you will be asked to answer a series of questions. That webpage will provide instruction for providing the required information. Proceed by selecting the Web Link Option 1 or 2 as applicable: 1. ___I received this notice and the information above does not apply. 2. ___I received this notice and will call in reference to the information above. Please Note: If your beds are installed with both rubberized castor cups and dual beds have been secured you must still notify us that you have received this notice and understand what is requested of you. RESOLUTION: Issue 1. If you require to be supplied with rubberized castor cups or need as
- Recall number
- Z-1500-2022
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1499-2022, Z-1500-2022. The agency record governs; check it and the company before acting.