Epimed International recalls NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

Recall date

December 28, 2017

Source

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

Recall number

Z-2313-2021

FDA classification

Class II

Brand / firm

Epimed International

Sold / distributed

Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.

Why it was recalled

Potential for stylet to protrude from the distal end of the catheter

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

What was recalled

NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile