Epimed International, Inc. recalls 15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epi…

Recall date

April 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0086-2017

FDA classification

Class II

Brand / firm

Epimed International, Inc.

Sold / distributed

US Distribution to the states of : AL, AK, FL, IN, TN & TX

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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