Merit Convenience Kits containing Cytosol Ophthalmics recall: Endotoxin
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Why was Merit Convenience Kits containing Cytosol Ophthalmics recalled?
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All convenience kits containing Part Number 8118, all lot numbers.
- Product
- Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
- Recalling firm
- Merit Medical Systems, Inc
- Quantity
- 2470 kits
- Distribution
- Connecticut, Maryland, Ohio, and South Carolina.
- Recall date
- November 14, 2012
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)