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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Buttonhole Needle Set		see related information
Date Posted January 24, 2013
Recall Number Z-0714-2013
Product 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.
Code Information Lot: 120719F4
Recalling Firm/
Manufacturer		 Medisystems a NX Stage Company
350 Merrimack St
Lawrence, Massachusetts 01843-1748
Consumer Instructions Contact the recalling firm for information
Reason for
Recall		 A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
Action Medisystems sent a notification letter dated December 20, 2012 to affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to immediately open and inspect inventory for the affected products. Results of the inspection are to be provided to Medisystems and the product is to be returned to Medisystems. For questions call (978) 332-5973.
Quantity in Commerce 26 casesx 250 needles (6500needles)
Distribution US Nationwide Distribution in the states of NY, PA and TN.
 
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