Events

Rappel de Device Recall Presource Custom Sterile Surgical and Procedure Kits

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 Cardinal Health.

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
    61048
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1104-2012
  • Date de mise en oeuvre de l'événement
    2012-01-27
  • Date de publication de l'événement
    2012-02-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107172
  • 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
    General surgery tray (kit) - Product Code LRO
  • Cause
    The presource kits were assembled with ethicon sutures in new tyvek packaging which could no longer be placed in kits that will undergo ethylene oxide sterilization.
  • Action
    The firm, Cardinal Health, sent an "URGENT: PRODUCT RECALL" letter dated January 26, 2012 to the affected consignees via UPS next day air. The letter identified the product, problem, and actions to be taken. Enclosed with the letter were recall labels, instructing the customer not to use the affected sutures and to remove and destroy the sutures upon opening the kit, to affix recall label to the front side of each affected Presource kit and shipping carton currently in their inventory. The customers were also requested to complete and fax back to Cardinal at 847-689-9101 or 614-652-9648 regardless of whether or not you have inventory. For component credit/replacement the consignees were instructed to contact the following: Presource Sales Operations at 800-766-0706; Government Customer Service at 800-444-1166; and Distributor Management Group at 800-635-6021. For any questions, require additional labels or desire special assistance relating to this recall contact Cardinal Health Quality Systems, 800-292-9332.

Device

Device Recall Presource Custom Sterile Surgical and Procedure Kits
  • Modèle / numéro de série
    all recent lots of the following kit catalog numbers PC23OHCTF, PC40OH80J, PC40OH811, PC44GCCMB, PCCGOHEZD, PCOCOHC11, PCOCOHCVT, PE63EMGHB, PE8ATHCSA, PG21OTSYB, PG22CRBRB, PGOCMJSFA, PGVMTOBL4, PGVMTOBL5, PGVMTOBLP, PGW1GSBLM, PGW1OBMUN, PHOCTHMTG, PJ35IVSBA, PN08CRGHA, PN13CRMGC, PNOCCY09I, PO08SAGH3, PO08SAGHM, PO15HATRB, PO41EXCAK, PO41KSCA3, PO41KSCAM, PO42KNTM5, PO42KNTME, PO42KNTMF, PO42SATM2, PO42SATMF, PO42SATMG, PO45ARSJV, PO45UASJMO, PO60ARLHW, PO60SHLHQ, POCGAAMJN, POCGAKJCB, POCGASJCA, PODKLVSTH, PODKPSSTH, POHBAAVAE, POOCARHTN, POOCARHTO, POOCSHEEM, POVMFABHE, POW1AKWMK, PU8ARLCSA, PVOCAAAWPK, PVV1OTGSN, SAN11PTLH1, SAN13INMTM, SAN19PIVAA, SAN19SBFMF, SAN23PLMU3, SAN23PLMU4, SAN23PLMUG, SAN23PLMUH, SAN23PLNCE, SAN30LHTGB, SAN34CIAVH, SAN34FSAVF, SAN44PITCO, SAN49PTMBF, SAN49PTMBG, SAN51INUCH, SAN56PIIHJ, SAN56RPIHG, SAN59DRTCG, SAN69SPWWI, SAN8FMAUAE, SAN8FMAUAF, SANCGPCAUB, SANCGPCAUC, SANW1CIHFA, SBA11TEWHF, SBA11THMME, SBA12LPHEB, SBA13BRLOG, SBA13RPBWD, SBA22BADRT, SBA23CTMUC, SBA23LBSGB, SBA34URMTE, SBA51CAEBG, SBA57UAOHG, SBA69CRSNB, SBA69HPCIK, SBA69PEWWI, SBA8FGRGMA, SBAOCBBASE, SCV11BORJP, SCV31PICMA, SCV33OHSM6, SCV73BHHGH, SCV7CVAGR1, SCV7CVAGRE, SEN41RNSUH, SER11LCCHD, SER11LCCHE, SLC12LPUVN, SNE11CANSN, SNE12CRKGA, SNE23SSRCL, SNE36CRWVL, SNE69VPWWF, SNU49CLM01, SNU49CLMBT, SOP11APIHD, SOP11ARHTI, SOP11ARJMP, SOP11ARNUK, SOP11ARPHI, SOP11ARWAC, SOP11RALHM, SOP11SHEEH, SOP11SHLHH, SOP11SHNUG, SOP13ARCYM, SOP13ARMSN, SOP13ARSHF, SOP13FFBI2, SOP13FTAKH, SOP13HAMEA, SOP13HNSFC, SOP13MAAKF, SOP13MOMHD, SOP13SAMSO, SOP13SHSFC, SOP14ARLM1, SOP14ARLMD, SOP18KNCOJ, SOP18SHCOH, SOP19ARMLK, SOP19KAVAI, SOP19UEMLF, SOP19UEMLG, SOP21KNSTD, SOP21SHSTC, SOP23ARRGC, SOP23SHCTB, SOP23SHCTC, SOP23SPCMB, SOP24ARJHA, SOP24HAOZA, SOP24KPOZB, SOP24SHJHA, SOP24SHOZB, SOP25ACCHF, SOP25ARVAF, SOP25SHCHG, SOP26HDSHF, SOP2RAROSB, SOP2RSPMB3, SOP2RSPMBD, SOP2RSPOSA, SOP31ARWSM, SOP32ARRVG, SOP32CTMCF, SOP32OHTRK, SOP33ARVDK, SOP33KADWI, SOP34HABSE, SOP34KAWSG, SOP35HNJWP, SOP35KAJWP, SOP35PHJWP, SOP35UXJWM, SOP36AKCOJ, SOP36KASUH, SOP40HAPSB, SOP40HPRVB, SOP41ARHGD, SOP41ARSMB, SOP41HNHMK, SOP41KSAGD, SOP41PASUI, SOP41SHAGD, SOP41SHHGB, SOP42BSSKL, SOP42KASKE, SOP42LHSKN, SOP42MCSKG, SOP42RHSKJ, SOP42SASKH, SOP42SHSLB, SOP42SMSKF, SOP42SSSKJ, SOP43KNSUB, SOP43RSMPA, SOP43SHMPB, SOP44ARBBI, SOP44SABBJ, SOP45ACCUE, SOP45ARUVA, SOP45KSCUF, SOP45SAHCB, SOP45SSCUD, SOP48ARHAI, SOP4BKACOF, SOP51HPBJE, SOP53CTOCC, SOP53SPBSD, SOP54ARDYG, SOP55ARWMJ, SOP61PDRHO, SOP63FHKHJ, SOP69CAFCG, SOP69CSFCE, SOP69KAOID, SOP69SHOID, SOP73ACCML, SOP73KACMB, SOPCGAHAUB, SOPCGAHAUC, SOPCGHNBJC, SOPCGKPBJC, SOPCGKPBJD, SOPCNHASDB, SOPHDARSMB, SOPOCHASAB, SOPOCKAASD, SOPOCKALIA, SOPW1SHBOG, SOT30RPVRF, SRH41HTTRB, SRI63LXULE, SRI63UXULF, SRIHT0861N and SRIOR0730S
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (Nationwide) including the states of: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, West Virginia, Wisconsin and Washington; and country of Canada.
  • Description du dispositif
    Presource Custom Sterile Surgical and Procedure Kits containing Ethicon Ethilon Black Nylon Nonabsorbable Surgical Sutures in new Tyvek packaging; surgical trays; Cardinal Health. 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 ethylene oxide sterilized and are ready to be used by the customer for the specific procedure. || 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 ethylene oxide sterilized and are ready to be used by the customer for the specific procedure.
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Adresse du fabricant
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    USFDA