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U.S. Department of Health and Human Services

Class 2 Device Recall Dolomite Gloss

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 Class 2 Device Recall Dolomite Glosssee related information
Date Initiated by FirmJune 15, 2023
Date PostedAugust 23, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2445-2023
Recall Event ID 92645
Product Classification Walker, mechanical - Product Code ITJ
ProductDOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR
Code Information Serial number in the range: 20BHL0002 to 21IHL1910
Recalling Firm/
Manufacturer		 Invacare Corporation
1200 Taylor St
Elyria OH 44035-6248
For Additional Information ContactRecall Support
877-431-6008
Manufacturer Reason
for Recall		Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user
FDA Determined
Cause 2		Device Design
ActionInvacare initiated on June 15, 2023 via electronic communications Urgent Medical Device Field Correction to consignees. Letter states reason for recall, health risk and action to take: 1. Review your existing stock to locate, quarantine, and return the affected devices to Invacare. A list of serial numbers is attached to assist in this process. An example product label for is shown below with annotations. 2. For affected Dolomite Gloss rollators already delivered to a customer, please contact the customer immediately to inform them that the Dolomite Gloss rollator(s) that they purchased is/are part of a safety recall and that use of this product should be discontinued immediately. For convenience, we have attached a Customer Letter which you may use to communicate this information with your customer(s). 3. Invacare will work with you to provide a replacement rollator or credit for the affected rollator that is being returned. 4. Complete and return the enclosed Provider Acknowledgement Card by following the instructions on the card. If you do not have an acknowledgement card or require a new one, please contact Invacare at (877) 413-6008 (U.S. Customers), Monday Friday, 8 a.m. 5 p.m. EST, for assistance. 5. You are responsible for ensuring that this field correction is conducted with your customers. Customers who own affected units should be contacted and informed about this field correction. If you have any questions concerning these instructions, please call Invacare s field correction support line at (877) 413-6008 (U.S. Customers), Monday Friday, 8 a.m. 5 p.m. EST, for assistance.
Quantity in Commerce586 devices
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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