Class I Medical Device Recall: Lee Medical International Inc., Custom Dialysis Trays/Kits
Recall Class: Class I
Date Recall Initiated: March 22, 2011
Products: Custom Dialysis Trays/Kits (For product names, lot/serial numbers, expiration dates, and BIN numbers, please see table below).
These products were manufactured from January 13, 2011 through March 21, 2011 and distributed from February 9, 2011 through March 21, 2011.
See related recall under Additional Links below.
Use: The custom dialysis kits are designed to include all the components (gloves, bandages, fistula needles, antibacterial pads [Povidone Iodine (PVP) Prep Pads], and specific bloodlines) used in preparing hemodialysis vascular access sites for patients undergoing dialysis procedures.
612 Distributors Row
Harahan, Louisiana 70123-3206
Reason for Recall: These custom dialysis trays/kits contain PVP Prep Pads that were recalled by H & P Industries. The pads may not be sterile. Patients receiving hemodialysis who use the pads may be at potential risk for serious or life threatening infection.
Public Contact: Customers may contact the company at 1-800-433-8950.
FDA District: New Orleans
Summary of Recall: On March 22, 2011, the company notified their customers (hospitals and clinics) by email and by telephone.
|Product Names, Lot Numbers, Expiration Dates, BIN Numbers|
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.