Reported Jan 28, 2015 · Terminated
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:…
Arrow International Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arrow International Inc · 2400 Bernville Road · Reading, PA · 19605
Is this the product you have?
- Multi-Lumen PI CVC Kit and PSI Kit3-L 7 FR X 8
- product code
ASK-45703-POSU lot #23F13L0166exp. 31-Jul-2015:
- Product UsageMulti-Lumen
- PI CVC KitAn 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 KitA catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery
- Lot codes and dates
- Multi-Lumen PI CVC Kit3-L 7 FR X 8
- product code
ASK-45703-POSU lot #23F13L0166exp. 31-Jul-2015
- PSI Kit
8.5 FR X 4-1/8 (10 CM)product code ASK-09803-OSU2lot #23F14C1014exp. 31-Aug-2015:
- Amount recalled
- 420
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
the Instructions for Use (IFU) were inadvertently removed from the kit.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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