FDA recall Z-0087-2018

Product

RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter

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-0087-2018