Epimed International: Medical Device Recall in 2017 - (Recall #: Z-0087-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 24, 2017

Date Posted: November 15, 2017

Recall Number: Z-0087-2018

Event ID: 77842

Reason for Recall:

Potential for partially incomplete seal of product, impacting sterility.

Status: Terminated

Product Quantity: 500 units

Code Information:

Lot No. 12168200; Ref No. 107-1416.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated