Enforcement Report - Week of January 30, 2013
-
Back to Previous Page
Product Detail
| 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 |
|---|---|
| Recall Number | Z-0715-2013 |
| Classification | Class II |
| Code Info | Lot: Number: 110914F8 |
| Product Distributed Qty | 16 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 |
Event Detail
| Event Id | 63959 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Medisystems a NX Stage Company |
| City | Lawrence |
| State | MA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-20 |
| Initial Firm Notification of Consignee or Public | |
| Distribution Pattern | US Nationwide Distribution in the states of NY, PA and TN. |
-
