The Recall Desk
HighFDA (Devices)·Z-0004-2020·Announced 2019-10-09

Metrix Secure EVA Dual Chamber IV Bags Recalled for Leaking

The Metrix Company is recalling 14,1120 Secure EVA dual chamber IV bags due to a potential for leaking. The affected products were distributed in the US and Canada.

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 involves a medical device with a risk of harm (leaking) where no specific injuries or illnesses have been reported, fitting the criteria for a High severity score.

Plain-English summary

The Metrix Company is recalling 14,1120 units of the SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL (REF 66616). The recall is being conducted because of a potential for the product to leak. These containers are intended for use in intravenous admixture programs for the storage and delivery of parenteral admixtures.

The affected products were distributed in the US, including the states of Pennsylvania, Massachusetts, Illinois, and California, as well as in Canada. The recall includes specific lot numbers ranging from 66616-A2442 to 66616-A5669.

Healthcare facilities and pharmacies should stop using the affected products and contact The Metrix Company for instructions on how to return them.

The recalled product

Product
SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - 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 u
Manufacturer
The Metrix Company
Hazard
Affected units
141,120

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 (20)

  • Lot Numbers: 66616-A2442
  • 66616-A2524
  • 66616-A2725
  • 66616-A2906
  • 66616-A2974
  • 66616-A3033
  • 66616-A3309
  • 66616-A3310
  • 66616-A3318
  • 66616-A3520
  • 66616-A3554
  • 66616-A3559
  • 66616-A3737
  • 66616-A3773
  • 66616-A3794
  • 66616-A3977
  • 66616-A4081
  • 66616-A4147
  • 66616-A4443
  • 66616-A4516

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 8 recalled by The Metrix Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · The Metrix Company

See all →