FDA Device Recall Z-0008-2020: The Metrix Company

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0008-2020.

Recall Res Number

Z-0008-2020

Recalling Firm / Manufacturer

The Metrix Company

FEI Number

1000117446

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2018-09-21

Date Posted

N/A

Date Terminated

N/A

Product Code

KPE

Event Number

83509

Product Quantity

332640 bags

Product Description ExactaMix, Model: H938905, EMPTY EVA DUAL CHAMBER CONTAINER With Screw Connectors, 250 ml/ 1250 ml, Baxter - 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

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

Code Information / Serial Numbers Lot Numbers: H938905 63630-A1769, H938905 63630-A1771, H938905 63630-A1773, H938905 63630-A2647, H938905 63630-A2649, H938905 63630-A2651, H938905 63630-A2655, H938905 63630-A2657, H938905 63630-A2659, H938905 63630-A2661, H938905 63630-A3950, H938905 63630-A3952, H938905 63630-A3954, H938905 63630-A3956, H938905 63630-A3957, H938905 63630-A3959, H938905 63630-A3961, H938905 63630-A3963, H938905 63630-A3965, H938905 63630-A3968, H938905 63630- A5338, H938905 63630-A5340, H938905 63630-A5342, H938905 63630-A5344, H938905 63630-A5346, H938905 63630-A5348, H938905 63630-A5350

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Medical Device Recall: Z-0008-2020

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer