Z-1252-2021 Class II Terminated
FDA device recall Z-1252-2021 was initiated by Cardinal Health 200, LLC on February 9, 2021 and is designated Class II. 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 The recall status is terminated (terminated April 9, 2024). Affected quantity: 6800 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 24, 2021
- Initiation Date
- February 9, 2021
- Termination Date
- April 9, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6800 units
Product Description
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
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
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of AE, Japan.
Code Information
Lot Code: 028610, 028611