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Class I: serious health riskTerminated

Merit Convenience Kits containing Cytosol Recall

Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Sin…

Merit Medical Systems, Inc · South Jordan, UT

Risk level
Class I
Reported by FDA
Nov 14, 2012
Recall ID
D-040-2013
Check your lot numberHow we source this data

Summary

Merit Medical Systems recalled Merit Convenience Kits containing Cytosol starting Feb 24, 2006. The FDA classified it as Class I (serious health risk) and published enforcement report D-040-2013 on Nov 14, 2012. Reason: Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.

Product description

Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.

Lot numbers, UPCs & expiration codes

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

Where it was sold

Connecticut, Maryland, Ohio, and South Carolina.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-040-2013
Classification
Class I
Status
Terminated
Recall initiated
Feb 24, 2006
FDA report date
Nov 14, 2012
Quantity
2470 kits
Recall type
Voluntary: Firm initiated
Recalling firm
Merit Medical Systems, Inc

Original FDA data

Every field from FDA enforcement report D-040-2013, exactly as published.

Show all FDA fields
City
South Jordan
State
UT
Status
Terminated
Country
United States
Event ID
35255
Address
1600 West Merit Pkwy
Code information
All convenience kits containing Part Number 8118, all lot numbers.
Postal code
84095-2416
Report date
Nov 14, 2012
Product type
Drugs
Recall number
D-040-2013
Classification
Class I
Recalling firm
Merit Medical Systems, Inc
Product quantity
2470 kits
Termination date
Feb 28, 2013
Reason for recall
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Distribution pattern
Connecticut, Maryland, Ohio, and South Carolina.
Recall initiation date
Feb 24, 2006
Initial firm notification
Telephone
Center classification date
Nov 6, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-040-2013, published Nov 14, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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