FDA-Device2017-11-15Class II
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
Epimed International
Hazard
Potential for partially incomplete seal of product, impacting sterility.
Sold states
Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
Affected count
500 units
Manufactured in
13958 Diplomat Dr, N/A, Farmers Branch, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0087-2018Don't want to check this manually?
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