Recall Z-1106-2021— Arrow International Inc

Name: FDA recall Z-1106-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-06

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2021-01-06, terminated 2022-07-12. It names one FDA 510(k) clearance: K993691. Product: Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A. Reason: The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product as a coated ARROWg+ard Blue PLUS (AGB+) antimicrobial catheter which may cause a minor delay during use and placement of a coated catheter in patients with known sensitivity to chlorohexidine, silver sulfadiazine or sulfa could result in an allergic reaction.

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2021-01-06
Terminated: 2022-07-12
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 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A

Reason for recall

The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product as a coated ARROWg+ard Blue PLUS (AGB+) antimicrobial catheter which may cause a minor delay during use and placement of a coated catheter in patients with known sensitivity to chlorohexidine, silver sulfadiazine or sulfa could result in an allergic reaction

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