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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
Recall Number Z-1633-2014
Classification Class II
Code Info MF2016829 RM2072044 RM2034076 RM2095792 RM2056629 RM3015571 RM2069733
Product Distributed Qty 4285
Reason For Recall The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinician were to place the needle under x-ray with the assumption that the component was echogenic, the needle would appear less prominently than expected but would still be visible.

Event Detail

Event Id 67833
Product Type Devices
Status Ongoing
Recalling Firm Arrow International Inc
City Reading
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution only to MI.