Exact FDA event identifier

Event 35255

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: February 24, 2006
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Merit Medical Systems, Inc

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-040-2013

Recall number: D-040-2013
Initiated: February 24, 2006
Classification: Class I
Status: Terminated
Recalling firm: Merit Medical Systems, Inc
Quantity: 2470 kits

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Connecticut, Maryland, Ohio, and South Carolina.