Device product
U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization.
Z-0355-2016
Product summary
- Event
- Event 72596
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1100 pieces
- Official record key
device-enforcement:Z-0355-2016
Official wording
Reason: The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle
Code information: Lot 9184-A
Distribution pattern: Distributed in the states of MT and NY.
Derived failure modes
-
Unknown
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle