Recall Z-2819-2018— Arrow International Inc

Name: FDA recall Z-2819-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-10

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2018-07-10, terminated 2020-05-27. It names one FDA 510(k) clearance: K862056. Product: HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.. Reason: The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2018-07-10
Terminated: 2020-05-27
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

HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use only with Arrow One-Piece Percutaneous Sheath Introducer System, Material HO-14703 The central venous catheter permits venous access to the central circulation through an indwelling Arrow percutaneous sheath introducer.

Reason for recall

The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed.

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