CLASS II Device recall · Reported 16 Jan 2013 · FDA Enforcement Report
Merit Medical's Custom Procedural Tray or Kits K12T-03162B & recalled
Merit Medical Systems is recalling Merit Medical's Custom Procedural Tray or Kits K12T-03162B &, distributed in Mississippi, New Jersey. The recall was initiated on 14 Sep 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0663-2013
- FDA event ID
- 63231
- Recalling firm
- Merit Medical Systems, Chester, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Sep 2012
- FDA classified
- 10 Jan 2013
- Reported
- 16 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Other Medical Devices
Timeline
| 14 Sep 2012 | Recall initiated by company | |
| 10 Jan 2013 | Classified by FDA | +118 days |
| 16 Jan 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
Distributed in Mississippi and New Jersey.
Questions about this recall
Is Merit Medical's Custom Procedural Tray or Kits K12T-03162B & recalled?
Yes. Merit Medical Systems recalled Merit Medical's Custom Procedural Tray or Kits K12T-03162B & on 14 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0663-2013.
Why was it 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 lots are affected?
Tray and Kit - K12T-03162B & K12T-02641F/ Lots #T243169, Exp. 2012-12, T276753, Exp. 2013-04, T282465, Exp. 2013-02, T259844, Exp. 2013-02, T265274, Exp. 2013-02, Chloride Injection Lot 05-201-JT
Where was it sold?
Distributed in Mississippi and New Jersey.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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