MediChoice Dual-Release Folding Walker with 5" wheel

FDA device recall Z-0416-2015 · posted 2014-11-20 · Terminated

Recall details

Recalling firm

Owens & Minor Distribution, Inc.

Reason for recall

Product wheels may be too loose, too tight, or fall off.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

ITJ

Quantity affected

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.

Date initiated

2014-06-25

Date posted

2014-11-20

Date terminated

2017-01-06

Location

Mechanicsville, VA