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Recall Observatory FDA recall evidence

Device product

Magellan 3 mL Syringe with 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: 8881833558

Z-1252-2021

February 09, 2021

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 87313
Status
Terminated
Classification
Class II
Quantity
6800 units
Official record key
device-enforcement:Z-1252-2021

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: 028610, 028611

Distribution pattern: Worldwide distribution - US Nationwide distribution and the countries of AE, Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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