Recall: Lee Medical International Inc., Custom Dialysis Trays/Kits
The FDA is reporting a recall of custom dialysis trays/kits made by Lee Medical Int’l. 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. To learn more about the recall click here.
Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order under statutory authority. A Class I recall, like the Lee recall, occurs in a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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