Device product
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patients vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials. PSI Kit: A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.
Z-1005-2015
Product summary
- Event
- Event 70017
- Status
- Terminated
- Classification
- Class II
- Quantity
- 420
- Official record key
device-enforcement:Z-1005-2015
Official wording
Reason: the Instructions for Use (IFU) were inadvertently removed from the kit.
Code information: Multi-Lumen PI CVC Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015 PSI Kit: 8.5 FR X 4-1/8 (10 CM), product code ASK-09803-OSU2 , lot #23F14C1014, exp. 31-Aug-2015:
Distribution pattern: In the state of KY
Derived failure modes
-
Unknown
the Instructions for Use (IFU) were inadvertently removed from the kit.