Recall Z-0416-2015 ยท ITJ Walker, Mechanical
Owens & Minor Distribution, Inc.
MediChoice Dual-Release Folding Walker with 5" wheel
| Date | Nov 20, 2014 (initiated Jun 25, 2014) |
| Status | Terminated |
| Reason | Product wheels may be too loose, too tight, or fall off. |
| Root cause | Employee error |
| Action | Customers were notified via letter and email by June 27, 2014. to take the following actions: 1. Designate a quarantine location in the DC for the recalled lots and serial numbers. 2. Label this area very clearly as "RECALLED PRODUCT IN QUARANTINE". 3. Clearly segregate the area to prevent the product from being moved or handled and to further designate that the product is in quarantine. 4. Record each case lot# or walker serial number if the product is out of the case on the recall inventory report. 5. Label each unit in the quarantine area with a label that clearly states RECALLED PRO |
| Quantity | 1214 cases; 4 units/case |
| Distribution | US Distribution including the states of CA, CO, CT, GA, IL, MA, MD, ME, MI, NE, NH, NJ, NY, OH, OR, PA, SC, TX, UT, VA, VT, WA and WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.