FDA Recall Open, Classified

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.

Recall: Z-0006-2020 · Initiated September 21, 2018

Recall

Recall Number
Z-0006-2020
Event Number
83509
Firm
The Metrix Company
FEI Number
1000117446
Product Code
KPE
Status
Open, Classified
Root Cause
Process control
Initiated
September 21, 2018
Address
4400 Chavenelle Rd, Dubuque, IA, 52002-2655

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

Potential for leaking product

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.

Distribution

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

Quantity

54720 bags