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Epimed International, Inc. recalls 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an ep
Recalled November 9, 2016 · FDA recall Z-0086-2017 · Epimed International
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. · FDA Class II
Units
576 units
Sold at
US Distribution to the states of : AL, AK, FL, IN, TN & TX
Description
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.
Product
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
Manufacturer(s)
Epimed International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →