Recall Z-0006-2020— The Metrix Company

Name: FDA recall Z-0006-2020
Creator: U.S. Food and Drug Administration
Published: 2018-09-21

Class II · Ongoing

Class II FDA medical device recall by The Metrix Company, initiated 2018-09-21. It names one FDA 510(k) clearance: K960581. 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 use of this product is for storage and delivery of intravenous parenteral admixtures.. Reason: Potential for leaking product.

Recalling firm: The Metrix Company
Classification: Class II
Status: Ongoing
Initiated: 2018-09-21
Firm location: Dubuque, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K960581 — SECURE EVA DUAL CHAMBER MIXING BAGSecure Medical Products, Inc.·cleared 1996-04-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 use of this product is for storage and delivery of intravenous parenteral admixtures.

Reason for recall

Potential for leaking product

Data sourced from openFDA. This site is unofficial and independent of the FDA.