Reported Mar 21, 2018 · Terminated
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R)…
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 Rd · Reading, PA · 19605-9607
Is this the product you have?
- Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and
- Sharps Safety Features Product UsageThe Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including
- but not limited to multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI
- Lot codes and dates
- ASK-42703-PRJ 13F16L0007 13F16M0013 13F17A0296 13F17D0110 13F17F0319
- Amount recalled
- 23,904 in total
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
Why it was recalled
Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.
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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