Custom Dialysis prep kits labeled as follows: ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP 5-12, BIN 34B; COMMUNITY-CATH, 150

FDA device recall Z-3260-2011 · posted 2011-09-23 · Terminated

Recall details

Recalling firm

Lee Medical International Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FKG

Quantity affected

4,075 units

Distribution

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

Date initiated

2011-08-15

Date posted

2011-09-23

Date terminated

2012-01-30

Location

Harahan, LA