Recall Z-2261-2016— The Metrix Company

Name: FDA recall Z-2261-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-23

Class II · Terminated

Class II FDA medical device recall by The Metrix Company, initiated 2016-06-23, terminated 2023-04-11. It names one FDA 510(k) clearance: K843523. Product: Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.. Reason: An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications..

Recalling firm: The Metrix Company
Classification: Class II
Status: Terminated
Initiated: 2016-06-23
Terminated: 2023-04-11
Firm location: Dubuque, IA, United States

510(k) clearances named in this recall

1 on FDA's record

K843523 — EMPTY SOLUTION TRANSFER CONTAINER 1000Polymer Technology Corp.·cleared 1984-10-16

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

Container fill and transfer sets, automatic fill compatible, 250 mL, 500 mL, 1000 mL, 1500 mL, 2000 mL, 3000 mL, or 4000 mL.

Reason for recall

An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

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