Medical device recalls Moderate risk

Arrow International Inc recalls ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B

Recall date
December 15, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1194-2018
FDA classification
Class II
Brand / firm
Arrow International Inc
Sold / distributed
Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.

Why it was recalled

Certain lots of peripheral catheter systems may be missing the safety latch, intended to minimize the risk of sharps injuries.

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

What was recalled

ARROW ENDURANCE" Extended Dwell Peripheral Catheter System, Catalog Numbers: EDC-00820 & EDC-00820-B

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