Recall Z-0087-2018— Epimed International

Name: FDA recall Z-0087-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-24

Class II · Terminated

Class II FDA medical device recall by Epimed International, initiated 2017-07-24, terminated 2023-07-06. It names one FDA 510(k) clearance: K053318. 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: Potential for partially incomplete seal of product, impacting sterility..

Recalling firm: Epimed International
Classification: Class II
Status: Terminated
Initiated: 2017-07-24
Terminated: 2023-07-06
Firm location: Farmers Branch, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K053318 — RX EPIDURAL NEEDLEEpimed International, Inc.·cleared 2006-02-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Reason for recall

Potential for partially incomplete seal of product, impacting sterility.

Data sourced from openFDA. This site is unofficial and independent of the FDA.