Recall Z-1251-2021— Cardinal Health 200, LLC

Class II · Terminated

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2021-02-09, terminated 2024-04-09. FDA's recall record names no specific 510(k) clearance for this event. Product: McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 26558. Reason: Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens.

Recalling firm
Cardinal Health 200, LLC
Classification
Class II
Status
Terminated
Initiated
2021-02-09
Terminated
2024-04-09
Firm location
Mansfield, MA, United States

Product description

McKesson PREVENT M NEEDLE (Magellan Technology) 25G X 5/8". A single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Product Code: 26558

Reason for recall

Safety shield not locking into the cannula. If the safety shield activation fails to lock a contaminated needle, a needlestick may occur and there is the potential for exposure to bloodborne pathogens

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