Metrix Secure EVA IV Bags Recalled for Potential Leaking
The Metrix Company is recalling 54,720 Secure EVA dual chamber IV bags due to a potential for leaking. The affected units 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 FDA classified this as a Class II recall. The hazard is a potential leak in a medical device used for intravenous administration, which poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Metrix Company is recalling 54,720 units of the SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL (REF 66641). The recall is being conducted because of a potential for the product to leak. These containers are used in intravenous admixture programs for the storage and delivery of parenteral admixtures.
The affected lots include 66641-A2630, 66641-A2683, 66641-A3005, 66641-A3560, 66641-A3796, 66641-A3979, 66641-A4220, 66641-A4473, 66641-A4543, 66641-A5066, 66641-A5283, 66641-A5412, 66641-A5556, and 66641-A5671. The source text indicates US nationwide distribution, specifically mentioning Pennsylvania, Massachusetts, Illinois, and California, as well as Canadian distribution.
Healthcare facilities and pharmacies should stop using the affected lots and contact The Metrix Company for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 4000mL, REF 66641 (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
- 54,720
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 (14)
- Lot Numbers: 66641-A2630
- 66641-A2683
- 66641-A3005
- 66641-A3560
- 66641-A3796
- 66641-A3979
- 66641-A4220
- 66641-A4473
- 66641-A4543
- 66641-A5066
- 66641-A5283
- 66641-A5412
- 66641-A5556
- 66641-A5671
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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