Device product
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
Z-0715-2013
Product summary
- Event
- Event 63959
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 cases (15 cs x 250 ea) 4,000 needles
- Official record key
device-enforcement:Z-0715-2013
Official wording
Reason: Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge
Code information: Lot: Number: 110914F8
Distribution pattern: US Nationwide Distribution in the states of NY, PA and TN.
Derived failure modes
-
Labeling or packaging
mislabeled