Device product
POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously.
Z-2254-2013
Product summary
- Event
- Event 66223
- Status
- Terminated
- Classification
- Class II
- Quantity
- 160 units
- Official record key
device-enforcement:Z-2254-2013
Official wording
Reason: Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter because it is mislabeled.
Code information: Lot no. I666473
Distribution pattern: Distributed in MI and TX.
Derived failure modes
-
Labeling or packaging
mislabeled