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Open, Classified

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

FDA Recall Z-0005-2020 · Posted None

Recalling FirmThe Metrix Company
Recall StatusOpen, Classified
Product CodeKPE
Date Initiated2018-09-21
Product Quantity234720 bags

Reason for Recall

Potential for leaking product

Firm Action

The Metrix Company notified the direct account (distributors) by telephone on 09/21/2019. The firm asked if the consignees received any complaints of leaking during the divider rod removal and return of any of the lot. The firm expanded the recall and disseminated the notices by email and telephone on 08/2/30/2019. Press was issued on 09/09/2019.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution including the states of PA, MA, IL CA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960581SECURE EVA DUAL CHAMBER MIXING BAGSecure Medical Products, Inc. · 1996-04-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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