Recall Z-0714-2013— 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: K990803. Product: Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.. Reason: A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5"..
- 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 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.
Reason for recall
A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
Data sourced from openFDA. This site is unofficial and independent of the FDA.