Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGua
FDA device recall Z-0715-2013 · posted 2013-01-24 · Terminated
Recall details
- Recalling firm
- Medisystems a NX Stage Company
- 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
- Action taken
- Medisystems sent a notification letter dated December 20, 2012 to affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to immediately open and inspect inventory for the affected products. Results of the inspection are to be provided to Medisystems and the product is to be returned to Medisystems. For questions call (978) 332-5973.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- FIE
- Quantity affected
- 16 cases (15 cs x 250 ea) 4,000 needles
- Distribution
- US Nationwide Distribution in the states of NY, PA and TN.
- Date initiated
- 2012-12-20
- Date posted
- 2013-01-24
- Date terminated
- 2013-10-10
- Location
- Lawrence, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDISYSTEMS HEMODIALYSIS FISTULA SET (K910734) | Medisystems Corp. | 1991-06-20 |