Enforcement Report - Week of January 16, 2013
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Product Detail
| 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. |
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| Recall Number | Z-0663-2013 |
| Classification | Class II |
| Code Info | 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 |
| Product Distributed Qty | 422 total kits/trays |
| 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 body. |
Event Detail
| Event Id | 63231 |
|---|---|
| Product Type | Devices |
| Status | Completed |
| Recalling Firm | Merit Medical Systems, Inc. |
| City | Chester |
| State | VA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-14 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Distributed in Mississippi and New Jersey. |
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