Reported Jun 11, 2014 · Terminated
Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access…
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?
- Arrow¿ Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
- Lot codes and dates
- Product codes and lot numbers
AK-09903-A23F13G0162AK-09903-SRF3064511CDC-09903-1A23F13G0642AK-09903-J23F13G0400ASK-09903-CMCRF3064673NL-09903-S23F13G0630AK-09903-LFSPRF3065449ASK-09903-CMC23F13G0343NR-09903-S23F13G0180AK-09903-S23F13G0204ASK-09903-NKC23F13G0336SI-09903-ERF3064710AK-09903-SRF3064956ASK-09903-TJ23F13G0567SI-09903-ERF3064915AK-09903-S23F13H0195CDC-09903-1ARF3065316
- Product codes and lot numbers
- Amount recalled
- 15424
Where it was sold
- Nationwide
Why it was recalled
Arrow is recalling the Arrow¿ Percutaneous Sheath Introducer Kits due to dilator tip damage noted during internal inspection. Dilator tip damage has the potential to result in vessel damage.
This product could cause temporary or reversible health problems — stop using it.
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