Events

Retiro De Equipo (Recall) de Cardinal Health Sterile Presource PBDS Modules

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Cardinal Health.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    36421
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0062-2007
  • Fecha de publicación del evento
    2006-10-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-05-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48729
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Drape - Product Code LRO
  • Causa
    The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.
  • Acción
    Cardinal Health sent separate recall letters dated 9/27/06 via UPS next day delivery to those accounts who ordered the drapes alone and those accounts who ordered custom sterile packs and PBDS modules, informing them that the cardiovascular split drapes may tear and/or fray at the reinforced fenestrated trough area during use. The letters listed the catalog numbers and affected lot numbers of the sterile drapes, and the letters sent to the pack and module customers were accompanied by a listing of catalog numbers and work order numbers for the affected packs ordered by each account. The accounts were requested to inspect their inventory to determine if they had any of the affected product on hand; segregate the affected inventories; complete and return via fax at 847-689-9101, the enclosed acknowledgment form, indicating the number of drapes in inventory being destroyed; and contact the El Paso Customer Service Center at 915-779-3681 to order replacement product. Distributors were requested to notify their customers of the recall. An additional letter dated 10/25/06 was sent via UPS overnight delivery to 49 of the accounts, expanding the recall to include lot 06HRD110 of catalog #9158, Convertors Tiburon Cardiovascular Split Drape II, Sterile. The instructions remained the same as those in the 9/27/06 letter.

Device

Cardinal Health Sterile Presource PBDS Modules
  • Modelo / Serial
    cat #PC40OHRJR, order #10054217, 10055120, 10057934; cat #PC40OHRJT, order #10065291, 10077187; cat #PWOCBSBSE, order #10060748;  cat #PC40CGSLK, order #10061804, 10066623;  cat #PCOCCGNYO, order #10065587;  cat #PCOCOHNME, order #10065687;  cat #PC40VPSLD, order #10043999;  cat #PC78OHUVZ, order #10060807, 10069028;  cat #PC82OH16C, order #10068824;  cat #PC82OH17O, order #10052174, 10054524, 10065426, 10065686;  cat #PCVROHDMI, order #10057971;  cat # PC15CGFCL, order #10064101;  cat #PCOCOHLLD, order #10065095;  cat #PG15OTFCI, order #10067619;  cat #PGCGLRLUP, order #10062174, 10068393;  cat #PC13OHEMR, order #10063121, 10070917;  cat #PC60CJICX, order #10067310;  cat #PCOCOHMMK, order #10055151, 10066811;  cat #PCV2CG34A, order #10047446;  cat #PCV2CP10J, order #10062941;  cat #PCV2VRNHW, order #10047450;  cat #PVOCAA76F, order #10066307;  cat #UCV42OPVC3, order #774231;  cat #PC92CBHRB, order #776785;  cat #PC44CGDEB, order #780376;  cat #PC22OHMHW, order #731809;  cat #PC23OPSFH, order #737659;  cat #PC43OHHRG, order #739410;  cat #PV24CAGME, order #740765; cat #PC40OHTJ1, order #10075965
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution- USA and countries of Kuwait and Australia
  • Descripción del producto
    Cardinal Health Sterile Presource PBDS Modules, have Presource Custom Sterile Packs containing the Cardiovascular Split Drape II or a Sterile Convertors Tiburon Cardiovascular Split Drape II bundled in the module; packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085; identified by the following catalog numbers: || PBDS modules containing catalog 9158: || a) PC40OHRJR - Basic Open Heart Kit, RWJ; || b) PC40OHRJT - Basic Open Heart Kit, RWJ; || PBDS modules containing custom sterile packs: || a) PWOCBSBSE - Breast Reduction Kit, pack SBA13BRBSE; || b) PC40CGSLK - CABG Kit, ***, pack SCV11CESLB; || c) PCOCCGNYO - CABG Kit, ***, pack SCV11OCNYN; || d) PCOCOHNME - Open Heart Kit, pack SCV11OHNMC; || e) PC40VPSLD - Valve Kit, pack SCV11VASLB; || f) PC78OHUVZ - Open Heart Kit, ***, pack SCV56CH11A; || g) PC82OH16C - Open Heart Kit, ***, pack SCV59MJTCW; || h) PC82OH17O - Open Heart Kit, pack SCV69OH17E; || i) PCVROHDMI - Open Heart Kit, pack SCV53HTDMG; || j) PC15CGFCL - CABG Kit, ***, pack SCV32CPMUO; || k) PCOCOHLLD - Open Heart Kit - Adult, pack SCV11ADLLD; || l) PG15OTFCI - General Surgery Kit, Fairview, pack SBA32GSMUL; || m) PGCGLRLUP - Liver Transplant Kit 747340, pack SBA31LVLUM; || n) PC13OHEMR - Open Heart Adult Pk Kit, pack SCV13AMEMJ; || o) PC60CJICX - Cardiac Major Kit, pack SCV11CJICL; || p) PCOCOHMMK - Open Heart AB Kit, ***, pack SCV11HEMMI; || q) PCV2CG34A - G 3 CABG Kit, ***, pack SCV11CBNYP; || r) PCV2CP10J - CABG Kit, ***, pack SCV11CGCPR; || s) PCV2VRNHW - G 3 Valve Kit, ***, pack SCV11VLNYM; || t) PVOCAA76F - AAA Kit, ***, pack SCV13AABSV || u) UCV42OPVC3 - *** Open Heart Kit, pack SCV42OPVCG; || v) PC92CBHRB - *** CABG 2 of 2 Kit, pack SCV92CBHRB; || w) PC44CGDEB - *** CV Kit, pack SCV44CVDEB; || x) PC22OHMHW - *** Open Heart Kit, pack SCV22OHMES; || y) PC23OPSFH - *** Open Heart Kit, pack SCV23AOSFH; || z) PC43OHHRG - *** Open Heart Kit, pack SCV43OHHRF; || aa) PV24CAGME - *** CABG Kit, pack SCV24CAGME; || bb) PC40OHTJI - Open Heart Kit, pack SCV11MJTJI
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Dirección del fabricante
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA