FDA recall Z-0089-2018

Epimed International · Class II · device

Product

TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only

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-0089-2018