Merit Medical Recalls Custom Procedural Trays Due to Particulate Matter
Merit Medical Systems is recalling 422 Custom Procedural Trays and Kits because of particulate matter found in the 0.9% Sodium Chloride Injection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes potential risks of harm such as inflammation, phlebitis, and embolization, but does not report confirmed injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Merit Medical Systems, Inc. is recalling 422 units of Custom Procedural Trays and Kits, specifically models K12T-03162B and K12T-02641F. These kits are combinations of legally marketed medical devices placed in one container for user convenience. The recall is due to the presence of particulate matter in the 0.9% Sodium Chloride Injection contained within the kits.
The recall was initiated after one confirmed customer report identified four separate particulate issues in four individual flexible containers. The affected lots include T243169, T276753, T282465, T259844, and T265274, as well as Chloride Injection Lot 05-201-JT. The products were distributed in Mississippi and New Jersey.
The particulate matter may result in local inflammation, phlebitis, generalized low-level allergic response, or embolization to other organs. Consumers and healthcare facilities should stop using these specific kits and contact Merit Medical Systems for further instructions.
The recalled product
- 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 use
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Procedural Kits
- Affected units
- 422
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Tray and Kit - K12T-03162B & K12T-02641F/ Lots #T243169
- Exp. 2012-12
- T276753
- Exp. 2013-04
- T282465
- Exp. 2013-02
- T259844
- T265274
- Chloride Injection Lot 05-201-JT
Distribution
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