Recall Z-1118-2019— Arrow International Inc

Name: FDA recall Z-1118-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-10

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2019-01-10, terminated 2020-06-04. It names one FDA 510(k) clearance: K862056. Product: Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132. Reason: The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct.

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2019-01-10
Terminated: 2020-06-04
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K862056 — [CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIPArrow Intl., Inc.·cleared 1986-08-25

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¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132

Reason for recall

The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct

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