Reported Jun 21, 2017 · Terminated
1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous…
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?
4 of 4 products
| # | Product as published |
|---|---|
| 1 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit |
| 2 | Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 3)Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue Plus (R) Catheter and Sharps Safety Features |
| 3 | Multi-Lumen Pressure Injectable Central Venous Catheterization Kit with Blue Flex Tip(R)ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features 5)Pressure Injectable ARROWg+ard Blue Plus (R) Multi-Lumen Central Venous Catheterization Kit 6)AGB+Multi-Lumen Central Venous Catheterization Kit |
| 4 | AGB+Pressure Injectable Multi-Lumen CVC Kit The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access. Catheter, Intravascular, Therapeutic, Short Term Less Than 30 days |
- Lot codes and dates
- Material number
ASK-12703-PLV1ASK-15703-PLVASK-15703-PRHASK-42703-PRJASK-45703-PRHASK-45703-PRWJ1AK-42703-P1AAK-45703-P1ACA-42703-P1ACA-45703-P1ACDA-42703-P1ACDA-42802-P1ACDA-45703-P1ADevice Listing D040746
- Material number
- Amount recalled
- 27,485 units distributed in U.S., 4,371 units distributed internationally
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
- Nationwide
Why it was recalled
Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
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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