FDA Device

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,

Hazard

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.

What You Should Do

Remedy

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.

Products

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-
Brand
Lee Medical International Inc
UPC
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.

Units Affected

4,075 units