FDA Recall D-040-2013
Merit Medical Systems, Inc · South Jordan, UT
Class I — life-threatening Terminated 2561 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Reason for recall
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Recall record
- Recall number
D-040-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- Connecticut, Maryland, Ohio, and South Carolina.
- Recall initiated
- 2006-02-24
- Classified by FDA Center
- 2012-11-06
- FDA published
- 2012-11-14
- Terminated
- 2013-02-28
- Recalling firm
- Merit Medical Systems, Inc
- Firm location
- South Jordan, UT