Events

Rappel de Device Recall PSS Select medical productsBiopsy Punches

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 Clorox Healthcare Holdings, LLC (dba HealthLink).

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
    64888
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1655-2013
  • Date de mise en oeuvre de l'événement
    2013-03-18
  • Date de publication de l'événement
    2013-07-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-02-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118318
  • 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
    Punch, surgical - Product Code LRY
  • Cause
    Due to lack of sterilization.
  • Action
    On March 19, 2013, HealthLink sent their customers letters instructing them to do the following: 1) Screen their inventory and quarantine the product. 2) Notify all customers that received the affected products and ask them to return the lots to their firm. 3) Complete the attached form and return the lots to HealthLink Distribution center. For further assistance, customers were directed to call customer service at 1-800-638-2625.

Device

Device Recall PSS Select medical productsBiopsy Punches
  • Modèle / numéro de série
    1103316, 1100626, 1100625, 1100624, 1100623, 1100622, 1100621, 1100620, 1100619, 1100618, 1100617, 1100616, 1100615, 1100318, 1100317, 1100316, 1034725, 1034724, 1033414, 1031515, 1028733, 1028732, 1028723, 1028722, 1028721, 1028720, 1028719, 1028718, 1028717, 1028716, 1028715, 1028721, 1028722, 1028723, 1028706, 1028707, 1023914, 1023913, 1023912, 1023910, 1023908, 1023907, 1023904, 1023903, 1023902, 1023901, 1023114, 1023111, 1023110, 1023107, 1023106, 1023110, 1023111, 1023112, 1023113, 1023114, 1023115, 1023116, 1023117, 1023118, 1023119, 1023120, 1023121, 1023122, 1019605, 1019606, 1019607, 1019608, 1019609, 1019610, 1019615, 1019616, 1019617, 1019618, 1019619, 1015217, 1015216, 1015215, 1013315, 1013219, 1001861, 1001860, 1001859, 1001858, 1001857, 1001856, 1001854, 1001852, 1001851, 1001850, 1001849, 1001848, 1001847, 1001846, 1001845, 1001843, 1001842, 1001841, 1000527, 1000526, 1000525, 1000518, 0935203, 0935202, 0935201, 0934418, 0931016, 0931015, 0931013, 0931012, 0931011, 0931009, 0931008, 0931007, 0931006, 0931005, 0931004, 0930216, 0930215, 0930214, 0930213, 0927931, 0927930, 0927929, 0927928, 0927927, 0927926, 0927924, 0927923, 0927922, 0927921, 0927920, 0927919, 0927128, 0927127, 0927126, 0927125, 0927124, 0927123, 0927122, 0927121, 0927120, 0926021, 0926020, 0926019, 0926018, 0926017, 0926016, 0926015, 0923116, 0923019, 0923018, 0923017, 0922516, 0922515, 0921533, 0921532, 0921529, 0921526, 0921525, 0921524, 0921523, 0921523, 0921522, 0921517, 0919724, 0919723, 0919722, 0919720, 0919719, 0919718, 0919715, 0919714, 0919713, 0919712, 0919711, 0917612, 0917321, 0917320, 0917319, 0917318, 0917316, 0916228, 0916227, 0916225, 0916223, 0916221, 0916219, 0914718, 0914717, 0914716, 0914715, 0913326, 0913324, 0913323, 0913322, 0913321, 0911413, 0911412, 0911410, 0911408, 0911403, 0911401, 0909922, 0909920, 0909918, 0909913, 0907901, 0907819, 0907720, 0907719, 0907618, 0905824, 0905821, 0905820, 0905819, 0905818, 0905815, 0905814, 0905813, 0905812, 0905807, 0905804, 0905802, 0904319, 0903522, 0901335, 0901333, 0901332, 0901329, 0901327, 0901325, 0901324, 0901323, 0901322, 0901321, 0901319, 0901318, 0834723, 0834721, 0834720, 0834719, 0834321, 0834318, 0834317, 0834316, 0832616, 0832615, 0832614, 0832213, 0832212, 0831918, 0831917, 0831916, 0831915, 0831714, 0831713, 0831017, 0831016, 0831015, 0830415, 0829817, 0829816, 0829815, 0829514, 0829513, 0828717, 0826812, 0826612, 0826314, 0825214, 0823812, 0823811, 0823214, 0823115, 0822618, 0822617, 0819320, 0819319, 0819318, 0819316, 0819315, 0815815, 0815813, 0815812, 0815811, 0815810, 0811616, 0811615, 0811614, 0807319, 0807315, 0807314, 0807115, 0806513, 0805919, 0805917, 0805121, 0805119, 0804519, 0803518, 0802418, 0801517, 0800320, 0800319, 0800318, 0800317, 0736517, 0735515, 0735117, 0734818, 0734817, 0734417, 0734117, 0732517, 0732317, 0729217, 0728817.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico and the states of AZ, CA, CO, FL, GA, IA, IL, IN, MI, MO, MS, MT, NC, NJ, NY, OH, SC,TX ,VA ,WA, WI, and HI, and the countries of Canada, Mexico, and New Zealand.
  • Description du dispositif
    PSS Select medical products***Biopsy Punches*** || Disposable manual instrument for skin biopsy.
  • Manufacturer
    Clorox Healthcare Holdings, LLC (dba HealthLink)

Manufacturer

Clorox Healthcare Holdings, LLC (dba HealthLink)
  • Adresse du fabricant
    Clorox Healthcare Holdings, LLC (dba HealthLink), 3611 Saint Johns Bluff Rd S Ste 1, Suite 1, Jacksonville FL 32224-2679
  • Société-mère du fabricant (2017)
    The Clorox Company
  • Source
    USFDA