Status
Terminated
Drug Enforcement D-040-2013
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Classification
Class I
Report Date
November 14, 2012
Termination Date
February 28, 2013
Product Information
- Product description
- Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
- Product quantity
- 2470 kits
- Reason for recall
- Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
- Recall initiation reason
- —
- Initial firm notification
- Telephone
- Distribution pattern
- Connecticut, Maryland, Ohio, and South Carolina.
Location & Firm
- Recalling firm
- Merit Medical Systems, Inc
- Address
-
1600 West Merit Pkwy, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-040-2013
- Event ID
- 35255
- Recall initiation date
- February 24, 2006
- Center classification date
- November 6, 2012
- Code info
- All convenience kits containing Part Number 8118, all lot numbers.
- More code info
- —