Recall Z-0715-2013— Medisystems a NX Stage Company
Class II · Terminated
Class II FDA medical device recall by Medisystems a NX Stage Company, initiated 2012-12-20, terminated 2013-10-10. It names one FDA 510(k) clearance: K910734. 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. Reason: Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge needles instead of 17 Gauge.
- Recalling firm
- Medisystems a NX Stage Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-12-20
- Terminated
- 2013-10-10
- Firm location
- Lawrence, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.