Device Recall Custom dialysis prep kits

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution (USA) - including states of: AZ, CA, FL, GA, MD, NJ, NM, NY, PA, and TX.
  • Description du dispositif
    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
  • 1 Event

Fabricant

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