Device 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.
Z-0714-2013
Product summary
- Event
- Event 63959
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26 casesx 250 needles (6500needles)
- Official record key
device-enforcement:Z-0714-2013
Official wording
Reason: A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".
Code information: Lot: 120719F4
Distribution pattern: US Nationwide Distribution in the states of NY, PA and TN.
Derived failure modes
-
Labeling or packaging
mislabeled