FDA-Device2019-10-09Class IIPACKAGING DEFECT
Metrix Company SECURE EVA IV admixture containers recalled for potential leaking
OTHERNationwide distribution
Stop using recalled Metrix IV containers
The Metrix Company is recalling SECURE EVA dual-chamber containers (1500mL, REF 66615) used to hold intravenous medications in pharmacies. These containers may leak, which could affect the sterility and safety of the medication inside. The recall affects 1,596 bags with lot numbers 66615-A3539 and 66615-A5098.
- Check your pharmacy inventory for lots 66615-A3539 and 66615-A5098
- Stop using recalled containers immediately
- Contact The Metrix Company or the FDA for instructions on returning or disposing of affected bags
- Review any IV admixtures prepared in these containers
Hazard
Potential for leaking product
Sold states
US Nationwide distribution including the states of PA, MA, IL CA.
Affected count
1596 bags
Manufactured in
4400 Chavenelle Rd, N/A, Dubuque, IA, United States
Products
SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - 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 use of this product is for storage and delivery of intravenous parenteral admixtures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2020Don't want to check this manually?
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