Recall Z-0204-2015— Roscoe Medical Inc
Class II · Terminated
Class II FDA medical device recall by Roscoe Medical Inc, initiated 2014-10-01, terminated 2017-02-22. FDA's recall record names no specific 510(k) clearance for this event. 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). Reason: The caster may separate completely from the device frame causing injury to user..
- Recalling firm
- Roscoe Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-01
- Terminated
- 2017-02-22
- Firm location
- Strongsville, OH, United States
Product description
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)
Reason for recall
The caster may separate completely from the device frame causing injury to user.
Data sourced from openFDA. This site is unofficial and independent of the FDA.