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Terminated

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, BIN 39A and SANTACLA-CATH, 75/CS, LOT #A1118, EXP 7-12, BIN 44A. Product Usage: custom dialysis prep kits

FDA Recall Z-3260-2011 · Posted 2011-09-23

Recalling FirmLee Medical International Inc
Recall StatusTerminated
Product CodeFKG
Date Initiated2011-08-15
Date Terminated2012-01-30
Product Quantity4,075 units

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.

Firm Action

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 [email protected] or [email protected].

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution (USA) including the states of: CA, FL, GA, IA, LA, MD, NY and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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