Z-0715-2013 Class II Terminated
FDA device recall Z-0715-2013 was initiated by Medisystems a NX Stage Company on December 20, 2012 and is designated Class II. 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 The recall status is terminated (terminated October 10, 2013). Affected quantity: 16 cases (15 cs x 250 ea) 4,000 needles.
Recall Details
- Product Type
- Devices
- Report Date
- January 30, 2013
- Initiation Date
- December 20, 2012
- Termination Date
- October 10, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 cases (15 cs x 250 ea) 4,000 needles
Product Description
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
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
Distribution Pattern
US Nationwide Distribution in the states of NY, PA and TN.
Code Information
Lot: Number: 110914F8