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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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Product Detail

Product Description Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector
Recall Number Z-0715-2013
Classification Class II
Code Info Lot: Number: 110914F8
Product Distributed Qty 16 cases (15 cs x 250 ea) 4,000 needles
Reason For Recall Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge

Event Detail

Event Id 63959
Product Type Devices
Status Ongoing
Recalling Firm Medisystems a NX Stage Company
City Lawrence
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-20
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern US Nationwide Distribution in the states of NY, PA and TN.