Reported Nov 7, 2018 · Terminated
Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide…
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 Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including
- but not limited to the followingLack of usable peripheral IV sites, Central venous pressure monitoring, Total parenteral nutrition (TPN), Infusions of fluids, medications, or chemotherapy, and Frequent blood sampling or receiving blood transfusions/blood products
- Lot codes and dates
- 23F16C0071
- Amount recalled
- 105
Where it was sold
Why it was recalled
The product was shipped after its expiry date due to a system error. The product lidstock identifies the correct expiration date however the accompanying purchase order shipping documentation identifies an incorrect expiration date. Per standard clinical practice the lidstock would most likely be checked prior to use and the product would not be used leading to a minor delay while a replacement is located. In the unlikely event that the product lidstock is not checked prior to use, there is potential for use of expired product, and product functionality/or sterility cannot be guaranteed.
This product could cause temporary or reversible health problems — stop using it.
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