Recall Z-0204-2015 ยท ITJ Walker, Mechanical
Roscoe Medical Inc
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)
| Date | Nov 12, 2014 (initiated Oct 1, 2014) |
| Status | Terminated |
| Reason | The caster may separate completely from the device frame causing injury to user. |
| Root cause | 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 not |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.