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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 kitssee related information
Date Initiated by FirmAugust 15, 2011
Date PostedSeptember 23, 2011
Recall Status1 Terminated 3 on January 30, 2012
Recall NumberZ-3260-2011
Recall Event ID 59877
Product Classification Tray, start/stop (including contents), dialysis - Product Code FKG
ProductCustom 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
Code Information 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. 
FEI Number 2316883
Recalling Firm/
Manufacturer		 Lee Medical International Inc
612 Distributors Row
Harahan LA 70123-3206
For Additional Information ContactChris Smith
504-734-9336
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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.
Quantity in Commerce4,075 units
DistributionNationwide Distribution (USA) including the states of: CA, FL, GA, IA, LA, MD, NY and TX.
Total Product Life CycleTPLC 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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