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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description Continuous Peripheral Nerve Block Catheter Kit and Set Continuous Peripheral Nerve Block Catheter Kit and Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
Recall Number Z-0546-2014
Classification Class II
Code Info Product number AB-07200 Stimulator Adapter Cable with lot numbers: RF0059570, RF2069779, RF0088984, RF2108983, RF0128588, RF3052266, RF1071764.
Product Distributed Qty 121
Reason For Recall A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin.

Event Detail

Event Id 66589
Product Type Devices
Status Ongoing
Recalling Firm Arrow International Inc
City Reading
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: US (nationwide) including states of: MA, LA, CA, GA, KS, TX, PA, NY, MO, WI, NJ, MS, CT, ID, AL, CO, and PR; and Singapore.
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