Recall Z-0282-2019— Arrow International Inc

Name: FDA recall Z-0282-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-30

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2018-08-30, terminated 2020-07-31. It names one FDA 510(k) clearance: K993691. Product: 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.. Reason: 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..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2018-08-30
Terminated: 2020-07-31
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K993691 — ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERArrow Intl., Inc.·cleared 2000-03-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.