Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 16, 2013
Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identifie…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Merit Medical Systems, Inc. recalled Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom … - a moderate-severity action.
Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom … was recalled by Merit Medical Systems, Inc. in January 16, 2013. Reason: Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed…. Check the official notice for the remedy. Verify recall #Z-0663-2013 with the FDA Devices before acting.
The recall
Merit Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed….
- Moderate
- severity level
- Class II
- classification
- January 16, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0663-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0663-2013) was formally reported on January 16, 2013, with the manufacturer initiating the action on September 14, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Merit Medical Systems, Inc. is listed as the recalling firm, operating out of Chester, VA. Federal records list the affected scope as 422 total kits/trays.
The documented reason for this recall is: Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers… Distribution data in the federal record shows the product reached: Distributed in Mississippi and New Jersey.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
422 total kits/trays
Related Recalls
6
3 from same agency
Product description
Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.
Reason for recall
Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The particular matter may result acutely in local inflammation, phlebitis and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0663-2013 |
| Date reported | January 16, 2013 |
| Date initiated | September 14, 2012 |
| Recalling firm | Merit Medical Systems, Inc. |
| Firm location | Chester, VA |
| Affected scope | 422 total kits/trays |
| Distribution | Distributed in Mississippi and New Jersey. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0663-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.. Recalled by Merit Medical Systems, Inc.. Units affected: 422 total kits/trays.
Why was this product recalled? ▼
Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The particular matter may result acutely in local inflammation, phlebitis and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 16, 2013. Severity: Moderate. Recall number: Z-0663-2013.
Where was the recalled product distributed? ▼
Distribution: Distributed in Mississippi and New Jersey..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0663-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 16, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.