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U.S. Department of Health and Human Services

Class 2 Device Recall MediChoice DualRelease Folding Walker

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  Class 2 Device Recall MediChoice DualRelease Folding Walker see related information
Date Initiated by Firm June 25, 2014
Date Posted November 20, 2014
Recall Status1 Terminated 3 on January 06, 2017
Recall Number Z-0416-2015
Recall Event ID 68780
Product Classification Walker, mechanical - Product Code ITJ
Product MediChoice Dual-Release Folding Walker with 5" wheel
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;  
Recalling Firm/
Manufacturer		 Owens & Minor Distribution, Inc.
9120 Lockwood Blvd
Mechanicsville VA 23116-2015
For Additional Information Contact
804-723-7000
Manufacturer Reason
for Recall		 Product wheels may be too loose, too tight, or fall off.
FDA Determined
Cause 2		 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 PRODUCT IN QUARANTINE. 6. Conduct a daily inventory verification check using to ensure the inventory still remains in quarantine. In addition, please forward a copy of this letter to hospital personnel in a position to notify patients who may have received and been discharged with a walker from the lots and serial numbers identified above. Hospital Customers: Contact your local DC Customer Service Representative who will assist in returning and replacing the recalled walker. Patients Who May Have Received a Recalled Walker from a Hospital: Contact Owens & Minor Mainstreet Customer Service at 1-800-818-6664 who will assist you in returning and replacing a walker.
Quantity in Commerce 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.
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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