Recall Z-0053-2020— Arrow International Inc

Name: FDA recall Z-0053-2020
Creator: U.S. Food and Drug Administration
Published: 2019-05-17

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2019-05-17, terminated 2020-09-24. It names one FDA 510(k) clearance: K900263. Product: Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access. Reason: Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2019-05-17
Terminated: 2020-09-24
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K900263 — ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETERArrow Intl., Inc.·cleared 1990-07-24

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

Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access

Reason for recall

Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.

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