FDA-Device2016-11-09Class II
15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
Epimed International, Inc.
Hazard
There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.
Sold states
US Distribution to the states of : AL, AK, FL, IN, TN & TX
Affected count
576 units
Manufactured in
141 Sal Landrio Dr, Crossroads Business Park, Johnstown, NY, United States
Products
15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0086-2017Don't want to check this manually?
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