FDAFDA · Food and drugs·Recall number Z-1005-2015
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.
Published January 28, 2015 · Recall initiated: December 16, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
the Instructions for Use (IFU) were inadvertently removed from the kit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arrow International Inc
- Distributor
- In the state of KY
- Lot
- 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:
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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