Z-0416-2015 Class II Terminated
FDA device recall Z-0416-2015 was initiated by Owens & Minor Distribution, Inc. on June 25, 2014 and is designated Class II. Reason for recall: Product wheels may be too loose, too tight, or fall off. The recall status is terminated (terminated January 6, 2017). Affected quantity: 1214 cases; 4 units/case.
Recall Details
- Product Type
- Devices
- Report Date
- November 26, 2014
- Initiation Date
- June 25, 2014
- Termination Date
- January 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1214 cases; 4 units/case
Product Description
MediChoice Dual-Release Folding Walker with 5" wheel
Reason for Recall
Product wheels may be too loose, too tight, or fall off.
Distribution Pattern
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.
Code Information
Item 1314077745. Lot#/Serial #s: 1304CA07A 1307000381-1307001520; 1306CA07A 1307001521-1307002184; 1307CA07A 1307002185-1307002888; 1309CA07A 1307002889-1307003292; 1310CA07A 1307003293-1307004044; 1311CA07A 1307004045-1307004752; 1312CA07A 1307004753-1307005236;