February 2006 FDA Recall Drug by Merit Medical Systems, Inc
D-040-2013 - Lack of Assurance of Sterility

This Class I drug recall was voluntarily initiated by Merit Medical Systems, Inc on February 24, 2006 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in Connecticut, Maryland, Ohio, and South Carolina. and the recall is currently terminated.

Recall Number: D-040-2013

Reason for Recall
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Initiated
02-24-2006
Reported
11-14-2012
Quantity
2470 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
35255
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is 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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Merit Medical Systems, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Connecticut, Maryland, Ohio, and South Carolina.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-28-2013
Product Description About Product Description
Full technical description of the product.
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.

Batch or Lot Expiration Information

Lot# All convenience kits containing Part Number 8118, all lot numbers.