ClearanceBrief
Recall Z-0147-2011 ยท INM Chair, With Casters

Winco, Inc.

Recalled chairs include the following: 2008 Model Numbers: 653N - Care Cliner, 654N - XL Care Cliner, 655N - Drop Arm Care Cliner, 657N - XL Drop Arm Care Cliner, 690N - Elite Care Cliner, 691N - XL Elite Care Cliner, 694N - Dual Swing-Arm Elite Care Cliner, 695N - XL Dual Swing-Arm Elite Care Cliner. 2009 Model Numbers: 6530 - Care Cliner, 6540 - XL Care Cliner, 6550 - Drop Arm Care Cli

DateOct 27, 2010 (initiated Sep 7, 2010)
StatusTerminated
ReasonWinco Mfg., LLC, Ocala, Florida is recalling their Care Cliner. Due to malfunctioning axles which become lose from the caster assembly. This chair is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Recalled chairs include the following: Care Cliner, XL Care Cliner, Drop Arm Care Cliner
Root causeDevice Design
ActionWinco sent an Urgent Device Recall letter dated October 1, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Replacement parts were sent out to the consignees and customers were asked to dispose of the defective casters. Any consignee not reponding by November 15, 2010, would receive an additional letter. The firm placed a follow up phone call to the non responding consignees after two weeks. Customers were advised to call 800-237-3377 or email customer service at customerservice@wincomfg.com with questions or concerns. For
Quantity18,522 casters
DistributionWorldwide Distribution - USA (all states except Vermont and Nebraska) and the countries of Belgium, Canada, Chile, Ireland, Kuwait, Netherlands, Saud Arabia, Singapore and United Arab Emirates.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.