Recall Z-2037-2019— Cardinal Health 200, LLC

Name: FDA recall Z-2037-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-30

Class II · Completed

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2019-04-30. It names one FDA 510(k) clearance: K854547. Product: Monoject Standard Hypodermic Needle Item code: 8881200029. Reason: Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product.

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Completed
Initiated: 2019-04-30
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K854547 — MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENESherwood Medical Co.·cleared 1986-02-04

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

Monoject Standard Hypodermic Needle Item code: 8881200029

Reason for recall

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

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