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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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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
Distribution Pattern US Nationwide Distribution in the states of NY, PA and TN.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 Lot: Number: 110914F8 Class II Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge 16 cases (15 cs x 250 ea) 4,000 needles Z-0715-2013
Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion. Lot: 120719F4 Class II A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5". 26 casesx 250 needles (6500needles) Z-0714-2013