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U.S. Department of Health and Human Services

Class 1 Device Recall Custom dialysis prep kits

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  Class 1 Device Recall Custom dialysis prep kits see related information
Date Initiated by Firm March 22, 2011
Date Posted September 07, 2011
Recall Status1 Terminated 3 on January 30, 2012
Recall Number Z-3120-2011
Recall Event ID 59692
Product Classification Tray, start/stop (including contents), dialysis - Product Code FKG
Product 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
Code Information 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
Recalling Firm/
Manufacturer		 Lee Medical International Inc
612 Distributors Row
Harahan LA 70123-3206
For Additional Information Contact Chris Smith
504-734-9336
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Material/Component 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.
Quantity in Commerce 19,625 units
Distribution Nationwide Distribution (USA) - including states of: AZ, CA, FL, GA, MD, NJ, NM, NY, PA, and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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