Recall Z-1250-2021— 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: Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). 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: 8881850558. 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
Magellan Hypodermic Safety Needle, 25 G x 5/8" (0.508 mm x 1.6 cm). 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: 8881850558
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.