||January 24, 2013
||Medisystems 17 Gauge x 1" inch AV Fistula Needle
Product Code: D9-2007MGLB
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
|Medisystems a NX Stage Company
350 Merrimack St
Lawrence, Massachusetts 01843-1748
|Single needle packs in each case ( 10 needles
per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
||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
||16 cases (15 cs x 250 ea) 4,000 needles
||US Nationwide Distribution in the states of NY, PA and TN.