FDA recall Z-2312-2021

Epimed International · Class II · device

Product

NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile

Reason for recall

Potential for stylet to protrude from the distal end of the catheter

Distribution

Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.

Key facts

Status
Completed
Initiation date
2017-12-28
Report date
2021-08-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Farmers Branch, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2312-2021