Arrow International Inc recalls Arrow AGB + Multi-Lumen CVC Kit, Cat. No. CDC-42703-B1A. Product Usage - The Arrow CVC is intended to provide short-ter…

Recall date

August 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0282-2019

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

US nationwide in the states of CA, FL, NC, and RI.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 following: Lack 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.