Device 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
Z-1250-2021
Product summary
- Event
- Event 87313
- Status
- Terminated
- Classification
- Class II
- Quantity
- 243,250 units
- Official record key
device-enforcement:Z-1250-2021
Official wording
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
Code information: Lot Code: 025221
Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of AE, Japan.
Derived failure modes
-
Unknown
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