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
FDA Recall Z-0715-2013 · Posted 2013-01-24
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Recalling FirmMedisystems a NX Stage Company
Recall StatusTerminated
Product CodeFIE
Date Initiated2012-12-20
Date Terminated2013-10-10
Product Quantity16 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
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
US Nationwide Distribution in the states of NY, PA and TN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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