Events

Rappel de Care Cliner

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Winco, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    56844
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0147-2011
  • Date de mise en oeuvre de l'événement
    2010-09-07
  • Date de publication de l'événement
    2010-10-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94620
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Chair, with casters - Product Code INM
  • Cause
    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.
  • 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.

Device

Care Cliner
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    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.
  • Manufacturer
    Winco, Inc.

Manufacturer

Winco, Inc.
  • Adresse du fabricant
    Winco, Inc., 5516 SW 1st Lane, Ocala FL 34474-9307
  • Société-mère du fabricant (2017)
    Winco Inc
  • Source
    USFDA