Events

Recall of Device Recall 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
    59692
  • Event Risk Class
    Class 1
  • Event Number
    Z-3120-2011
  • Event Initiated Date
    2011-03-22
  • Event Date Posted
    2011-09-07
  • 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=103347
  • 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
    Firm manufactured custom dialysis kits with povidone iodine (pvp) prep pads which were recalled by h & p industries. those pads were subsequently recalled due to possible bacterial contamination.
  • Action
    The firm, Lee Medical International Inc., notified their consignees by email and telephone on 03/22/2011. Consignees were instructed to pull 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

Device Recall Custom dialysis prep kits
  • Model / Serial
    KIDNEYCARE, LOT #A1160, EXP 7-12  MESCALERO-HEMO, LOT #B1113, EXP 8-12  DAV-MT-POCONO-H, LOT #B1123, EXP 8-12  ADV-CATH-ISL44, LOT #B1127 EXP 8-12  ADV-HEMO-15G, LOT #B1128, EXP 8-  NORTHHUDSON-C, LOT #B1134, EXP 8-12  NORTHHUDSON-H, LOT #B1135, EXP 8-12   JOHNHAYES-HEMO, SMALL GLOVES, LOT #B1143, B1144, and B1145. EXP 8-12  JOHNHAYES-HEMO, MEDIUM GLOVES, LOT #B1146 and B1147, EXP 8-12  JOHNHAYES-SUB, SMALL GLOVES, LOT #B1148, EXP 8-12  JOHNHAYES-SUB, SMALL GLOVES, LOT #B1149, EXP 8-12   SNCH-CATH, LOT #B1152, EXP 8-12   COMMUNITY-HEMO, LOT #B1156, EXP 8-12  FLAMS-HEMO, LOT #B1162, EXP 8-12   KINDEYSPA-HEMO, LOT #B1161, EXP 8-12  DAV-POCONO-H, LOT #C1107, EXP 9-12  DAV-POCONO-CATH, LOT #C1108, EXP 9-12  DAV-MT-POCONO-H, LOT #C1109, EXP 9-12  MESCALERO-HEMO, LOT #C1110, EXP 9-12  KIDNEYTRMT-HEMO, LOT #C1112 and C1123, EXP 9-12  DAV-POCONO-H, LOT #C1126, EXP 9-12  METHODIST-HEMO, LOT #C1139, EXP 9-12  KINGMAN-HEMO, LOT #C1141, EXP 9-12  DAV-PALMERTON-H, LOT #C1145, EXP 9-12  EMANUEL-CATH, LOT #C1146, EXP 9-12
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) - including states of: AZ, CA, FL, GA, MD, NJ, NM, NY, PA, and TX.
  • Product Description
    Custom dialysis prep kits labeled as follows: || KIDNEYCARE, 125/CS, LOT #A1160, EXP 7-12, BIN 35A, Lee Medical International, Inc., New Orleans, LA 70123 || MESCALERO-HEMO, 200/CS, LOT #B1113, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 || DAV-MT-POCONO-H, 200/CS, LOT #B1123, EXP 8-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123 || ADV-CATH-ISL44, 100/CS, LOT #B1127 EXP 8-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123 || ADV-HEMO-15G, 100/CS, LOT #B1128, EXP 8-12, BIN 34A, Lee Medical International, Inc., New Orleans, LA 70123 || NORTHHUDSON-C, 100/CS, LOT #B1134, EXP 8-12, BIN 42B, Lee Medical International, Inc., New Orleans, LA 70123 || NORTHHUDSON-H, 75/CS, LOT #B1135, EXP 8012, BIN 42B, Lee Medical International, Inc., New Orleans, LA 70123 || JOHNHAYES-HEMO, SMALL GLOVES, LOT #B1143, B1144, and B1145. EXP 8-12, 100/CS, Lee Medical International, Inc., New Orleans, LA 70123 || JOHNHAYES-HEMO, MEDIUM GLOVES, LOT #B1146 and B1147, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 || JOHNHAYES-SUB, SMALL GLOVES, 100/CS, LOT #B1148, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 || JOHNHAYES-SUB, SMALL GLOVES, LOT #B1149, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 || SNCH-CATH, 50/CS, LOT #B1152, EXP 8-12, BIN 43A, Lee Medical International, Inc., New Orleans, LA 70123 || COMMUNITY-HEMO, 125/CS, LOT #B1156, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 || FLAMS-HEMO, 125/CS. LOT #B1162, EXP 8-12, BIN 38B, Lee Medical International, Inc., New Orleans, LA 70123 || KINDEYSPA-HEMO, 125/CS, LOT #B1161, EXP 8-12, BIN 35B, Lee Medical International, Inc., New Orleans, LA 70123 || DAV-POCONO-H, 500/CS, LOT #C1107, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 || DAV-POCONO-CATH, 75/CS, LOT #C1108, EXP 9-12, BIN 43B, Lee Medical International, Inc., New Orleans, LA 70123 || DAV-MT-POCONO-H, 200/CS, LOT #C1109, EXP 9-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123 || MESCALERO-HEMO, 200/CS, LOT #C1110, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 || KIDNEYTRMT-HEMO, 125/CS, LOT #C1112 and C1123, EXP 9-12, BIN 45A, Lee Medical International, Inc., New Orleans, LA 70123 || DAV-POCONO-H, 500/CS, LOT #C1126, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 || METHODIST-HEMO, 150/CS, LOT #C1139, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 || KINGMAN-HEMO, 150/CS, LOT #C1141, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 || DAV-PALMERTON-H, 200/CS, LOT #C1145, EXP 9-12, BIN 43B, Lee Medical International, Inc., New Orleans, LA 70123 || EMANUEL-CATH, 100/CS, LOT #C1146, EXP 9-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123 || 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