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U.S. Department of Health and Human Services

Class 2 Device Recall Roscoe Transport Rollator

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  Class 2 Device Recall Roscoe Transport Rollator see related information
Date Initiated by Firm October 01, 2014
Date Posted November 12, 2014
Recall Status1 Terminated 3 on February 22, 2017
Recall Number Z-0204-2015
Recall Event ID 69367
Product Classification Walker, mechanical - Product Code ITJ
Product Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backrest and handy wire basket for storage. Item# 30192 Burgundy each/Item# 30194 Blue each..

Transport Rollator is a wheeled rollator with an additional push bar that can be used to push an end-user for short trips. (Walker, Mechanical)
Code Information 30194, Roscoe Transport Rollator, Blue 30192, Roscoe Transport Rollator, Burgundy MH140401502-MH140401890 MH140500217-MH140500466 MH140406602-MH140406891 MH140407092-MH140407291 
Recalling Firm/
Manufacturer		 Roscoe Medical Inc
21973 Commerce Pkwy
Strongsville OH 44149-5558
For Additional Information Contact
650-204-7318
Manufacturer Reason
for Recall		 The caster may separate completely from the device frame causing injury to user.
FDA Determined
Cause 2		 Device Design
Action The firm, Roscoe Medical, issued a "URGENT RECALL NOTICE-Timely Response Required" Quarantine Communication to customers between 09/08/2014 and 09/10/2014. The notice identified affected products as 30194, serial number range MH140407092MH140407291, the problem and actions to be taken. The customers were instructed NOT to use this product and to destroy any affected product that may be in their inventory/control; immediately complete and return the attached Recall Response Form/Certificate of Destruction to Roscoe Medical- "Transport Rollator Recall" within 15 days of receipt of the recall notification via fax to (440) 572-4261 or email: corporate@roscoemedical.com, even if you do not have any affected product; and notify your customers immediately of this product recall. Should you have any questions, contact Roscoe Medical Customer Support at (800) 376-7263 Monday-Friday 8:00 am EST - 5:00 pm EST.
Quantity in Commerce 831 units
Distribution Nationwide Distribution: US including states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA< MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI,and WY.
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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