Metrix Secure EVA Dual Chamber IV Bags Recalled for Leaking
The Metrix Company is recalling 234,720 Secure EVA dual chamber IV bags due to a potential for leaking. The affected units were distributed nationwide in the US.
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 234,720 units of the SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL (REF 66631). 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 product was distributed nationwide in the United States, including the states of Pennsylvania, Massachusetts, Illinois, and California. The recall covers specific lot numbers, including 66631-A2443, 66631-A2564, and 66631-A2629, among others. The agency has classified this recall as Class II.
Healthcare facilities and pharmacies should check their inventory for the affected lot numbers and stop using the product. Users should contact The Metrix Company for further instructions regarding the return or disposal of the recalled items.
The recalled product
- Product
- SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 3000mL, REF 66631 (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
- Category
- Medical Device — IV Bags
- Hazard
- Affected units
- 234,720
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: 66631-A2443
- 66631-A2564
- 66631-A2629
- 66631-A2772
- 66631-A2975
- 66631-A3004
- 66631-A3311
- 66631-A3456
- 66631-A3483
- 66631-A3553
- 66631-A3558
- 66631-A3738
- 66631-A3774
- 66631-A3795
- 66631-A3978
- 66631-A4082
- 66631-A4148
- 66631-A4444
- 66631-A4517
- 66631-A5065
Distribution
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.
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