Events

Retiro De Equipo (Recall) de Presource Custom Sterile Surgical and Procedure Kits

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
    60069
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0169-2012
  • Fecha de publicación del evento
    2011-11-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104377
  • 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
    General surgery tray (kit) - Product Code LRO
  • Causa
    Some of the components contained in the presource kits are being recalled because cardinal health has determined that the component manufacturers do not have all necessary fda registrations or filings needed for these components.
  • Acción
    Cardinal Health issued an URGENT: PRODUCT RECALL letter dated September 30, 2011 to the affected wholesale consignees via UPS next day air, informing them that their Presource kits listed in the attached spreadsheet contain various components listed on the attachment, which are being recalled because the component manufacturer(s) do not have all the necessary FDA registrations or filings needed for these components. Enclosed with the letter were recall labels to affix to the front side of each affected Presource kit and shipping carton in their inventory. The labels have an ID code which coincides with the code on the component attachment to the letter. The accounts were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of pack/modules labeled. For component credit, the consignees were instructed to contact Distributor Management Group at 800-635-6021. This wholesale recall was expanded to include additional kits via letter dated October 5, 2011, with the same instructions as listed above. For questions regarding this recall call 800-292-9332.

Device

Presource Custom Sterile Surgical and Procedure Kits
  • Modelo / Serial
    all recent lots of the following kit catalog numbers PB53VDOCF, PB54ADSNO, PBCGCSEZC, PBCGDKEZC, PBHFVDLRG, PBVBSCNMK, PC21OHHOF, PC43CCLGC, PC43OH79D, PECGCL16M, PECGET16D, PEOCMEBL1, PEOCMEBLD, PEVTCESWV, PG69VSUS1, PG69VSUSF, PGCGOTUI8, PH76OTMDS, PH76TCMDR, PL23CSAML, PL23VDMPY, PL29OTRMU, PL41CSHSO, PL41VD16I, PL41VD87F, PL42VGTMG, PL42VGTMH, PL42VGTMI, PL54OTSMG, PL57DVSCI, PL57SCSCG, PL73CSSJU, PL73FBDWC, PL81CS99M, PL81VDSFX, PL8FCSSVA,  PL8FVDSVB, PLCGLR52A, PLCGOTMJU, PLCGVD66B,  PLCNCSHSW, PLCNLRLVU, PLVBCSSFR, PLVQMBPAD,  PN46CRKMA, PN48NNCHB, PNCGSPCDR, PNOCCRBLF,  PNVMCFBHG, PNVMCRBHM, PP15ICFCK, PPOCLGBSN,  PU40TRSOJ, PUOCOTSO1, PW82BSTCQ, PZ15LRFCC,  PZ51BCA701, PZ51BCA70C, PZMHADFBH, PZMHNAKYG,  PZOCADBSD, PZOCADFRB, PZOCBCGVD, PZVBOTANMS,  PZVZOTMIE, SAM55AMQMC, SAN12MPWCD, SAN21MYHOD,  SAN23AGDHC, SAN23ANDHF, SAN26BTACB, SAN31PPELF,  SAN48CCCHP, SANHDMRUMA, SANHDPRPIA, SBA13BNMGC, SBA13BNMGD, SBA18LCSCJ, SBA24BBMMA, SBA33PMSMA, SBA33PMSMB, SBA44IRMDC, SBA4APEJHE, SBB32BBNMD, SBB32BBNME, SBB53BTEVD,  SBB55BBMMG, SCV19OHCH6, SCV22AOKMA, SCV43CVBRI,  SCV43OHMWQ, SCV44NUHWA, SCV51VCKKD, SCVHBHSTMC, SEN13ORBWK, SEN19BSFMF, SEN31NSLUQ, SEN31PPLUK, SEN31PPNMA, SEN31TALUP, SEN31THLUR, SEN51HDKKD, SEN5CEPGSC, SID51STKKA, SMA32EAHSA, SMA33EACBC, SNE11PMDO2, SNE11PMDOB, SNE12EPNEA, SNE19CRCHU, SNE32CPSV1, SNE32CPSVC, SNE32CPSVE, SNE32CPSVF, SNE35LFBHB, SNE35LMBHI, SNE36STWPH, SNE48LPWLC, SNE51LMKKG, SNU23BSCHF, SNU42BSNKC, SOP21BSDKC, SRI63ACUMC, SRIGS0049M, SRINU0546N, SRINU0546O, SRINU0866J, SRIOR0870H, SRIOR0870I, SRIOR0871K, SRIOR0871L, UMA24CE43T, UMA24VA439 and UMA24VA43S
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including California, Florida, Illinois, Kentucky, Minnesota, Missouri, Ohio, Tennessee, Washington, West Virginia and Wisconsin
  • Descripción del producto
    Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the following listed components for which Cardinal Health has been unable to confirm the manufacturer's compliance with section 502(o) of the FD&C; Act: || a) 24" Infant Tape Measure, component 30942P; || b) Silicone Tubing, component SFM3-4450; || c) Triple Dye Drug, 10 unit dose, component PM1022; || d) Assembly Swabstick, component PS004; || e) 18x26 Poly Lined Towel, component 8580Z; || f) Disposable Vein Stripper, component 63-0431; || g) Cotton Glove, Large, White, PR, NS, component 1051; || h) Cotton Glove, Medium, White, PR, NS, component 1051M; || i) 6 Inch Metric-Inch Ruler, component 18C-Thru; || The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure.
  • 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