FDA recall Z-1252-2021

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

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

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

Key facts

Status

Terminated

Initiation date

2021-02-09

Report date

2021-03-24

Termination date

2024-04-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1252-2021