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Device Recall RX2 COUDE Epidural Needle
Model / Serial
Lot No. 12168200; Ref No. 107-1416.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
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
Manufacturer
Epimed International
1 Event
Recall of Device Recall RX2 COUDE Epidural Needle
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Manufacturer
Epimed International
Manufacturer Address
Epimed International, 13958 Diplomat Dr, Farmers Branch TX 75234-8805
Manufacturer Parent Company (2017)
Epimed International Inc
Source
USFDA
Language
English
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