Events

Recall of Custom Dialysis prep kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Lee Medical International Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59877
  • Event Risk Class
    Class 1
  • Event Number
    Z-3260-2011
  • Event Initiated Date
    2011-08-15
  • Event Date Posted
    2011-09-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103919
  • Notes / Alerts
    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.
  • Extra notes in the data
    Tray, start/stop (including contents), dialysis - Product Code FKG
  • Reason
    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
  • Model / Serial
    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 Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) including the states of: CA, FL, GA, IA, LA, MD, NY and TX.
  • Product Description
    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
  • Manufacturer Address
    Lee Medical International Inc, 612 Distributors Row, Harahan LA 70123-3206
  • Manufacturer Parent Company (2017)
    Lee Medical International Inc.
  • Source
    USFDA