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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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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
Distribution Pattern US Distribution only to MI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. MF2016829 RM2072044 RM2034076 RM2095792 RM2056629 RM3015571 RM2069733 Class II 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. 4285 Z-1633-2014