The Recall Desk
HighFDA (Devices)·Z-0008-2020·Announced 2019-10-09

Baxter ExactaMix IV Bags Recalled for Potential Leaking

The Metrix Company is recalling Baxter ExactaMix IV bags due to a potential for leaking. The recall covers 332,640 units distributed nationwide.

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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

The Metrix Company is recalling Baxter ExactaMix, Model H938905, Empty EVA Dual Chamber Containers with Screw Connectors (250 ml/1250 ml). The recall involves 332,640 units of the product, which is used in intravenous admixture programs for the storage and delivery of parenteral admixtures.

The recall was initiated due to a potential for leaking product. The affected units were distributed nationwide, including the states of Pennsylvania, Massachusetts, Illinois, and California.

Consumers and healthcare facilities should stop using the recalled product and contact The Metrix Company for further instructions or a replacement.

The recalled product

Product
ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - 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 f
Manufacturer
The Metrix Company
Hazard
Affected units
332,640

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: H938905 63630-A1769
  • H938905 63630-A1771
  • H938905 63630-A1773
  • H938905 63630-A2647
  • H938905 63630-A2649
  • H938905 63630-A2651
  • H938905 63630-A2655
  • H938905 63630-A2657
  • H938905 63630-A2659
  • H938905 63630-A2661
  • H938905 63630-A3950
  • H938905 63630-A3952
  • H938905 63630-A3954
  • H938905 63630-A3956
  • H938905 63630-A3957
  • H938905 63630-A3959
  • H938905 63630-A3961
  • H938905 63630-A3963
  • H938905 63630-A3965
  • H938905 63630-A3968

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 →