Data Foundry

Medical device recalls 2013

Merit Medical's Custom Procedural Tray or Kits K12T-03162B &amp — Class II medical device recall Z-0663-2013

Terminated recall by Merit Medical Systems, Inc., reported 2013-01-16, distributed in MS, NJ. Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed

Recall numberZ-0663-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmMerit Medical Systems, Inc., Chester, VA, United States
Recall initiated2012-09-14
Classified2013-01-10
Reported by FDA2013-01-16
Terminated2013-01-14
DistributedMS, NJ
Quantity422 kits
Reason classesspecification failure
Lot numbers05-201-JT, 2012-12, 2013-02, 2013-04, T243169, T259844, T265274, T276753, T282465

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 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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0663-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.