Reported Nov 21, 2018 · Terminated
Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code…
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?
Arrow AGB+ Multi-Lumen CVC Kit7 Fr3 Lumen20cm catheter length.025 inch dia. spring-wire guideProduct
- Code CDC-45703-B1A - Product UsageThe multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use
- Lot codes and dates
- Lot/Batch Numbers13F17E0685 13F17F0562 13F17H0141 13F17K0340 13F18B0119 13R17E0685
- Amount recalled
- 3640
Where it was sold
Why it was recalled
The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the correct SWG size .025 . For other lots in scope the lidstock correctly states the SWG size .025 however the banner card states the incorrect SWG size .032 .
This product could cause temporary or reversible health problems — stop using it.
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