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Manufacturers
Epimed International
Manufacturer Address
Epimed International, 13958 Diplomat Dr, Farmers Branch TX 75234-8805
Manufacturer Parent Company (2017)
Epimed International Inc
Source
USFDA
3 Events
Recall of Device Recall TUOHY Epidural Needle
Recall of Device Recall COUDE Blunt Nerve Block Needle
Recall of Device Recall RX2 COUDE Epidural Needle
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3 devices in the database
Device Recall TUOHY Epidural Needle
Model / Serial
Lot No. 12358202; Ref No. 125-2035T.
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
TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
Device Recall COUDE Blunt Nerve Block Needle
Model / Serial
Lot No. 12608201; Ref No. 117-2260.
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
COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
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
One manufacturer with a similar name
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Epimed International, Inc.
Manufacturer Address
Epimed International, Inc., 141 Sal Landrio Dr, Crossroads Business Park, Johnstown NY 12095-3835
Manufacturer Parent Company (2017)
Epimed International Inc
Source
USFDA
Language
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