FDA recall Z-0088-2018

Epimed International · Class II · device

Product

COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile

Reason for recall

Potential for partially incomplete seal of product, impacting sterility.

Distribution

Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.

Key facts

Status
Terminated
Initiation date
2017-07-24
Report date
2017-11-15
Termination date
2023-07-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Farmers Branch, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0088-2018