Date Initiated by Firm | March 28, 2022 |
Create Date | June 09, 2022 |
Recall Status1 |
Terminated 3 on January 19, 2024 |
Recall Number | Z-1254-2022 |
Recall Event ID |
90171 |
Product Classification |
System, communication, powered - Product Code ILQ
|
Product | MedMinder Medication Dispenser- Intended to serve as a medication reminder to promote medication adherence with additional feature to communicate with emergency call center. |
Code Information |
Serial Numbers:
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|
Recalling Firm/ Manufacturer |
Medminder Systems, Inc. 30 Wexford St Needham MA 02494-2912
|
For Additional Information Contact | SAME 617-345-3275 |
Manufacturer Reason for Recall | Discontinuation of the Emergency Alert watch or pendant will no longer connect to the emergency alert system for all models. Older Model (legacy) without screen medical alert feature(button) removed
|
FDA Determined Cause 2 | Other |
Action | Medminder engaged a third-party vendor to perform the phone calls and notifications. The process was initiated on 03/28/2022. Initial contact via telephone and text message. Formal letter issued first week of April 2022, formal certified letters to all relevant customers notifying them of the removal of the pendant/watch and that it will no longer be supported (will no longer connect to the emergency alert system).
. As of this notification, the medical alert pendants and watches will not work when pressed to call for emergency services. Please put in trash.
Customers can still use the medical alert feature with the pill dispenser itself or call 911 or any other emergency system available to them. Older models (412 units) without the screen, the medical alert feature using the mechanical button has been removed and should not be relied on and there is no support for the red emergency alert button on your model of the MedMinder pill dispenser, and should not be used to contact emergency services. Please know that you should call 911 in the event of an emergency. If you were scheduled in the past for replacement of the pill dispenser with a newer model, it will be completed as scheduled. Notification letters were issued depending on the model being used by the customers as follows:
1. Letter to newer models regarding the accessory pendant only.
2. Letter to older models regarding the accessory pendant as well as the feature.
3. Introductory letter for subgroup of 29 customer with both older and newer
models.
|
Quantity in Commerce | 2701 units |
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|