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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 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.
Recall Number Z-0714-2013
Classification Class II
Code Info Lot: 120719F4
Product Distributed Qty 26 casesx 250 needles (6500needles)
Reason For Recall A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".

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.