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

FDA Recall #Z-1194-2018 — Class II — December 15, 2017

Recall #Z-1194-2018 Date: December 15, 2017 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

Arrow International Inc — Reading, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

305

Distribution

Distributed in the following U.S. states: CO, FL, IL, NC, PA, SC, and TX.

Code Information

Catalog Number: EDC-00820, Lot: 14X17C0039 (Expires February 2019); Catalog Number: EDC-00820-B, Lot: 13F17F0120 (Expires May 2019)

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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