Events

Rappel de Custom Dialysis prep 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 Lee Medical International 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
    59877
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-3260-2011
  • Date de mise en oeuvre de l'événement
    2011-08-15
  • Date de publication de l'événement
    2011-09-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103919
  • 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
    Tray, start/stop (including contents), dialysis - Product Code FKG
  • Cause
    The firm used alcohol triple swabstick and prep pads manufactured by h & p industries in the manufacture of their custom dialysis kits. those swabsticks and pads were subsequently recalled due to possible bacterial contamination.
  • Action
    The firm, Lee Medical International Inc., notified their consignees by email and telephone on August 17, 2011. Consignees were instructed to remove the affected product from stock, quarantine for re-processing, and return or destroy product. Lee Medical arranged for replacement product from alternate manufacturer to be sent to customers. For questions call Production Manager or Operations Manager at 504-734-9336 or email melissal@eleemedical.com or chriss@eleemedical.com.

Device

Custom Dialysis prep kits
  • Modèle / numéro de série
    ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP 5-12, BIN 34B;  COMMUNITY-CATH, 150/CS, LOT #K1052, EXP 5-12, BIN 36B;  COLUMBUS-CATH, 50/CS, LOT #1080, EXP 05-12, BIN 39B;  RENALSG-CATH, 75/CS, LOT #L1046, EXP 6-12, BIN 40B;  SUNYDOWN-HEMO, 100/CS, LOT #l1015, EXP 6-12, BIN 28A;  KIDNEYCARE 125/CS, LOT #l1070, EXP 6-12;  METHODIST-CATH, 75/CS, LOT #L1072, EXP 6-12;  METHODIST-HEMO, 150/CS, LOT #L1073, EXP 6-12;  MERCYMED-CATH, 75/CS, LOT #L1077, EXP 6-12, BIN 39A and SANTACLA-CATH, 75/CS, LOT #A1118, EXP 7-12, BIN 44A.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution (USA) including the states of: CA, FL, GA, IA, LA, MD, NY and TX.
  • Description du dispositif
    Custom Dialysis prep kits labeled as follows: || ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP 5-12, BIN 34B; || COMMUNITY-CATH, 150/CS, LOT #K1052, EXP 5-12, BIN 36B; || COLUMBUS-CATH, 50/CS, LOT #1080, EXP 05-12, BIN 39B; || RENALSG-CATH, 75/CS, LOT #L1046, EXP 6-12, BIN 40B; || SUNYDOWN-HEMO, 100/CS, LOT #l1015, EXP 6-12, BIN 28A; || KIDNEYCARE 125/CS, LOT #l1070, EXP 6-12; || METHODIST-CATH, 75/CS, LOT #L1072, EXP 6-12; || METHODIST-HEMO, 150/CS, LOT #L1073, EXP 6-12; || MERCYMED-CATH, 75/CS, LOT #L1077, EXP 6-12, BIN 39A and || SANTACLA-CATH, 75/CS, LOT #A1118, EXP 7-12, BIN 44A. || Product Usage: custom dialysis prep kits
  • Manufacturer
    Lee Medical International Inc

Manufacturer

Lee Medical International Inc
  • Adresse du fabricant
    Lee Medical International Inc, 612 Distributors Row, Harahan LA 70123-3206
  • Société-mère du fabricant (2017)
    Lee Medical International Inc.
  • Source
    USFDA