CARE CLINER 6530 (STD)/6540 (X-LG) products are labeled in part: "***CARE CLINER 6530/6540 (w/NYLON CASTERS)***Winco***I

FDA device recall Z-1457-2012 · posted 2012-04-25 · Terminated

Recall details

Recalling firm

Winco Mfg., LLC

Reason for recall

Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster's axle working itself out of the assembly under unconventional conditions. Should this

Action taken

Winco Mfg. sent an "URGENT DEVICE RECALL" letter dated February 1, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to complete the Caster Recall Replacement Form and return it to the firm's Customer Service Department via fax to 352-854-9544. Contact the Customer Service Department at 800 237-3377 for questions regarding this notice.

Root cause

Device Design

Status

Terminated

Product code

INM

Quantity affected

1,080 Casters (360 chairs)

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Canada and Singapore.

Date initiated

2012-02-06

Date posted

2012-04-25

Date terminated

2012-07-27

Location

Ocala, FL