Recall Z-2263-2016— The Metrix Company

Name: FDA recall Z-2263-2016
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: K960581. Product: Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 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

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

Dual Chamber Container fill with gravity/attached transfer sets, 250 mL / 1250 mL, 300 mL / 1700 mL, 500 mL / 2500 mL, 500 mL / 3500 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.