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U.S. Department of Health and Human Services

Class 2 Device Recall Care Cliner

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  Class 2 Device Recall Care Cliner see related information
Date Initiated by Firm September 07, 2010
Date Posted October 27, 2010
Recall Status1 Terminated 3 on May 20, 2011
Recall Number Z-0147-2011
Recall Event ID 56844
Product Classification Chair, with casters - Product Code INM
Product 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 Cliner, 6570- XL Drop Arm Care Cliner, 6900 - Elite Care Cliner, 6910 - XL Elite Care Cliner, 6940 - Dual Swing-Arm Elite Care Cliner, 6950 - XL Dual Swing-Arm Elite Care Cliner.
Code Information Recalled chairs include the following Models : 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 Cliner, 6570- XL Drop Arm Care Cliner, 6900 - Elite Care Cliner, 6910 - XL Elite Care Cliner, 6940 - Dual Swing-Arm Elite Care Cliner, 6950 - XL Dual Swing-Arm Elite Care Cliner.  Recalled model numbers are as folows:  6530-02, 6530-03, 6530-03-TB, 6530-04, 6530-06, 6530-07, 6530-08, 6530-08-TB-00-PB, 6530-14, 6530-15, 6530-15-00-00-00-00-LC, 6530-15-00-00-PB, 6530-16, 6530-17, 6530-17-TB, 6530-25, 65302N,  65302NT,  6530-30, 6530-31, 6530-33, 6530-37-00-00-PB, 6530-39, 6530-39-00-00-PB, 65303N,  65303N,  65304N,  65304NH,  65304NHT,  65304NT,  6530-63, 6530-63-TB, 65306N,  65306NH,  65307N,  65307NT,  65308N,  65308NT,  65314N,  65314NH,  65314NT,  65315N,  65316N,  65317N,  65317NT,  65330N,  65333NT,  65337N,  65341N,  65344N,  65360N,  65361N,  65362N,  65362NT,  65363N,  65363NT,  6540-02, 6540-03, 6540-04, 6540-04-00-HM, 6540-06, 6540-07, 6540-08, 6540-14, 6540-16-TB, 6540-17, 6540-17-TB, 65402N,  65402NT,  6540-30-00-00-PB, 6540-37, 6540-39, 6540-39-00-00-PB, 65403N,  65403NT,  65404N,  65404NH,  65404NHT,  6540-60, 6540-63-TB, 65406N,  65406NH,  65407N,  65408N,  65414N,  65414NT,  65415N,  65416N,  65417N,  65417NT,  65430N,  65437N,  65441N,  65442N,  65461NH,  65462N,  65465N,  6550-02, 6550-03, 6550-03-00-HM, 6550-04, 6550-06, 6550-13, 6550-14, 6550-14-00-00-PB, 6550-14-00-HM, 6550-16, 6550-17, 65502N,  6550-30-00-HM, 6550-34-00-00-PB, 6550-37, 6550-39-00-HM, 65503N,  65503NH,  65504N,  65504NL,  65504NT,  65504NT-DART,  65506N,  65506NH,  65507N,  65507NH,  65508N,  65514N,  65514NH,  65514NL,  65514NW,  65515N,  65516N,  65516NH,  65516NT,  65517N,  65517NCE,  65517NH,  65517NHT,  65525N,  65527N,  65527NH,  65528NH,  65530NH,  65532N,  65532NH,  65533N,  65537N,  65539N,  65539NH,  65541NL,  65544NW,  65561NL,  65562NH,  65562NL,  65567N,  65567NH,  6570-02, 6570-03, 6570-03-00-HM, 6570-07, 6570-14, 6570-14-00-00-PB, 6570-14-00-HM, 6570-17, 6570-17-00-00-PB, 6570-17-00-00-PC, 6570-17-TB,  65702N,  65702NT,  6570-39-00-HM,  65703N,  65703NH,  6570-41,  65704N,  65704NT,  6570-62, 6570-63-TB,  65706N ,  65706NH,  65707N,  65707NH,  65708N,  65708NT,  65714N,  65714NH,  65714NL,  65714NT,  65714NW,  65715N,  65716NH,  65717N,  65717NCE,  65717NH,  65725N,  65727NH,  65728NH,  65730N,  65730NH,  65732N,  65732NH,  65733N,  65737N,  65739N,  65739NH,  65741NH,  65741NL,  65761N,  65762N,  65762NH,  65762NL,  65763NH,  65766N,  65767NH,  6900-02, 6900-03, 6900-04, 6900-17, 69002N ,  6900-30, 6900-39 ,  69003N,  69003NH,  6900-41,  69004N,  6900-60, 6900-61, 6900-62, 6900-63, 6900-63-00-HM, 6900-63-TB,  69006N,  69007N,  69008N,  69008NH,  69014N,  69014NT,  69014NW,  69015N,  69016N,  69016NT,  69017N,  69017NH,  69026N,  69027N,  69028N,  69030N,  69030NH,  69031N,  69032N,  69033N,  69034N,  69037N,  69039N,  69041N,  69041NH,  69060N,  69062N,  69063N,  69063NH,  69063NT,  69065NT,  69066N,  69066NT,  69067N,  6910-03, 6910-06, 6910-17, 6910-32, 6910-33-00-HM, 6910-37-00-00-PB, 6910-37-TB, 6910-39,  69103N,  69104N,  6910-60, 6910-61, 6910-62, 6910-63,  69106N,  69107NT,  69114N,  69114NW,  69117N,  69117NH,  69117NT,  69127N,  69133N,  69133NT,  69134N,  69137N,  69162N,  69163N,  69167N,  6940-03, 6940-03-00-HT, 6940-04-TB-HT, 6940-06, 6940-06-TB-HM, 6940-07-TB, 6940-14, 6940-14-TB, 6940-15, 6940-15-00-HM, 6940-16, 6940-16-TB-HM, 6940-17, 6940-17-00-HM, 6940-17-TB-HM, 6940-19-TB-HM, 6940-26-TB, 6940-26-TB-HM, 6940-27-TB-HM, 69402N,  69402NT,  6940-30, 6940-32, 6940-32-TB, 6940-33-TB-HM,  69403N,  69403NH,  69403NT,  69403NW,  6940-41-TB-HM,  69404N,  69404NDH,  69404NH,  69404NHT,  69404NT,  69404NWT,  6940-60-TB-HT, 6940-62, 6940-62-TB, 6940-62-TB-HM, 6940-62-TB-HT, 6940-63-TB, 69406N,  69406NH,  69407N ,  69407NT,  69414N,  69414NH,  69414NT,  69415N,  69415NH,  69415NHT,  69416N,  69416NHT,  69416NT,  69417N,  69417NHT,  69417NT,  69417NW,  69419NHT,  69427NHT,  69429NT,  69430NH,  69432N,  69432NT,  69433N,  69433NH,  69433NHT,  69433NT,  69434N,  69434NHT,  69437NH,  69437NHT,  69441NHT,  69444ND,  69444NDH,  69460N,  69460NHT,  69460NWT,  69461NH,  69462N,  69462NHT,  69462NT,  69463N,  69463NH,  69463NT,  69463NWT,  69466NWT,  69467N,  6950-03, 6950-03-00-HT, 6950-04-00-HM, 6950-04-TB-HT, 6950-06-TB-HM, 6950-15, 6950-16-TB-HM, 6950-19-TB-HM, 6950-19-TB-HT, 6950-26-TB-HM, 6950-27-TB-HM, 69502NH,  6950-33, 6950-33-TB-HM, 6950-39-00-HM,  69503N,  69503N,  69503NH,  69503NT,  6950-41-00-HT,  69504N,  69504NH,  69504NW,  6950-60, 6950-60-TB-HT, 6950-62-00-00-PB, 6950-62-TB-HT, 69506NHT,  69514N,  69514NH,  69514NHT,  69514NT,  69515N,  69515NH,  69516N,  69516NHT,  69516NT,  69517N,  69517NH,  69517NHT,  69517NT,  69519NHT,  69527NHT,  69529NT,  69530NH,  69532N,  69532NT,  69533N,  69533NH,  69533NHT,  69534N,  69541NHT,  69544ND,  69560N,  69560NHT,  69560NWT,  69561N,  69561NH,  69562N,  69562NHT,  69563NH,  69563NWT.    
Recalling Firm/
Manufacturer		 Winco, Inc.
5516 SW 1st Lane
Ocala FL 34474-9307
For Additional Information Contact Steven Goodson
352-854-2929
Manufacturer Reason
for Recall		 Winco 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
FDA Determined
Cause 2		 Device Design
Action Winco 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 questions or concerns regarding this recall call 352-854-2929 x 110.
Quantity in Commerce 18,522 casters
Distribution Worldwide 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.
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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