FDA Device recall Z-0663-2013
Merit Medical's Custom Procedural Tray or Kits K12T-03162B &amp
- FDA Device
- Class II
- terminated
- Published 2013-01-16
On 2013-01-16 the FDA classified a Class II recall of Merit Medical's Custom Procedural Tray or Kits K12T-03162B &amp by Merit Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0663-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-14 |
| Published | 2013-01-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Merit Medical Systems |
| Distribution | MS, NJ |
Product
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
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
Identifiers
| code_info | Tray and Kit - K12T-03162B & K12T-02641F/ Lots #T243169, Exp. 2012-12, T276753, Exp. 2013-04, T282465, Exp. 2013-02, T…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0663-2013%22
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