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.
Recall
- Recall Number
- Z-0714-2013
- Event Number
- 63959
- Firm
- Medisystems a NX Stage Company
- FEI Number
- 3003464075
- Product Code
- FIE
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- December 20, 2012
- Posted
- January 24, 2013
- Terminated
- October 10, 2013
- Address
- 350 Merrimack St, Lawrence, MA, 01843-1748
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.
A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
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.
US Nationwide Distribution in the states of NY, PA and TN.
26 casesx 250 needles (6500needles)