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U.S. Department of Health and Human Services

Class 2 Device Recall Access Point Medical Heavy Duty Rollator

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  Class 2 Device Recall Access Point Medical Heavy Duty Rollator see related information
Date Initiated by Firm June 20, 2006
Date Posted November 07, 2006
Recall Status1 Terminated 3 on June 11, 2008
Recall Number Z-0154-2007
Recall Event ID 35919
Product Classification Rolling Walker - Product Code ITJ
Product Access Point Medical-Heavy Duty Rollator (rolling walker), Product Code RL12010HD, with seat, backrest, 8'' wheels with locks, maximum capacity 400 lbs.,and wire basket. Manufactured for Access Point Medical, St. Louis, MO. Made in China
Code Information All Rollators of this model number
Recalling Firm/
Manufacturer		 Access Point Medical LLC
Three City Place Drive
Suite 750
St. Louis MO 63141
For Additional Information Contact Richard A. Davis
314-255-2702
Manufacturer Reason
for Recall		 The fork component on the wheel of the Rollator can break due to the use of incorrect manufacturing material and/or molding processes.
FDA Determined
Cause 2		 Other
Action The recall was initiated by phone on or about 6/20/06, to determine how many Rollators the customer had in stock because they had received reports of Rollators coming out of the box with cracked forks. During the phone call, the customer was told that the recalling firm was bringing back their remaining inventory for inspection and that customer service would be calling them back to arrange for return. The recalling firm issued a '2nd Recall Notice' dated 10/10/06 via UPS between 10/11-13/06 explaining the reason for recall, requesting their customers to conduct a subrecall down to the consumer level and instructing that all of the Rollators be destroyed.
Quantity in Commerce Approximately 861 Rollators (total for both models under recalls Z-0154/0155-2007)
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.
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