Recall Z-1455-2020— Cardinal Health 200, LLC

Name: FDA recall Z-1455-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-15

Class II · Terminated

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2020-01-15, terminated 2020-12-04. It names one FDA 510(k) clearance: K123684. Product: Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.. Reason: Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-01-15
Terminated: 2020-12-04
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K123684 — SOL-CARE SAFETY NEEDLESol-Millennium Medical·cleared 2013-05-08

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 Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.

Reason for recall

Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.

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