Custom dialysis prep kits labeled as follows: KIDNEYCARE, 125/CS, LOT #A1160, EXP 7-12, BIN 35A, Lee Medical Internation

FDA device recall Z-3120-2011 · posted 2011-09-07 · Terminated

Recall details

Recalling firm

Lee Medical International Inc

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.

Action taken

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.

Root cause

Material/Component Contamination

Status

Terminated

Product code

FKG

Quantity affected

19,625 units

Distribution

Nationwide Distribution (USA) - including states of: AZ, CA, FL, GA, MD, NJ, NM, NY, PA, and TX.

Date initiated

2011-03-22

Date posted

2011-09-07

Date terminated

2012-01-30

Location

Harahan, LA