Reported Jun 21, 2017 · Terminated
1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen…
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 | ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit |
| 2 | ARROWg+ard Blue PSI Kit |
| 3 | ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit |
| 4 | ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins |
- Lot codes and dates
- Material number
CDA-21242-1ACDA-29803-1ACDC-21242-1ACDC-29803-1ACDC-29903-1A Device Listing D025768
- Material number
- Amount recalled
- 27,485 untis 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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