Imed EVA IV bags recalled for leaking during filling
The Metrix Company is recalling Imed EVA 500 mL IV bags because a limited number have been found to leak during filling. Affected lots were distributed nationwide in the U.S. and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall of a critical-use product (intravenous administration) with no reported illnesses or injuries. The leaking defect poses a risk of harm in a high-risk medical application where injury has not yet been reported.
Plain-English summary
Imed EVA 500 mL, 2-port empty plastic IV bags (REF IM68050) manufactured by The Metrix Company are being recalled due to leaking discovered during the filling process.
A limited number of units from the affected lots have been found to leak during filling. This poses a risk when the bags are used for intravenous fluid administration.
The recalled product was distributed nationwide across multiple U.S. states (Texas, Illinois, Ohio, Pennsylvania, Washington, Maryland, Utah, California, Massachusetts, Michigan, Florida, and Puerto Rico) and Canada. The affected lot numbers are 68050-A8320, 68050-A8435, and 68050-A8476. A total of 864 cases of 50 units each were affected.
The recalled product
- Product
- Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.
- Manufacturer
- The Metrix Company
- Hazard
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 (4)
- UDI/DI 00812496011329
- Lot Numbers: 68050-A8320
- 68050-A8435
- 68050-A8476
Distribution
Part of a larger recall action
This product is one of 16 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 16 products in this recall →Related recalls
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