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FDA-Device2019-10-09Class IIPACKAGING DEFECT

Metrix SECURE EVA IV admixture containers recalled for potential leaking

The Metrix
OTHERNationwide distribution

Stop using Metrix SECURE EVA containers

The Metrix Company is recalling SECURE EVA dual chamber containers (3000mL, REF 66630) used to store intravenous medications in pharmacies. These containers may leak, which could compromise the sterility and safety of IV medications. The recall affects 4,284 bags in specific lot numbers distributed nationwide.

  • Stop using affected SECURE EVA containers (REF 66630, lots 66630-A2771 and 66630-A4282)
  • Check your pharmacy inventory for these lot numbers
  • Contact your supplier or The Metrix Company for instructions on return or disposal
  • Review any IV admixtures prepared in these containers with your pharmacy director
Hazard

Potential for leaking product

Sold states
US Nationwide distribution including the states of PA, MA, IL CA.
Affected count
4284 bags
Manufactured in
4400 Chavenelle Rd, N/A, Dubuque, IA, United States
Products
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0002-2020

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