Recall Z-2336-2017— Arrow International Inc

Name: FDA recall Z-2336-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-09

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-05-09, terminated 2018-09-17. It names one FDA 510(k) clearance: K862056. Product: Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.. Reason: The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or chemotherapy -infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values -frequent blood sampling or blood/blood components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access.

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-05-09
Terminated: 2018-09-17
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 Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.

Reason for recall

The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or chemotherapy -infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values -frequent blood sampling or blood/blood components infusions -infusion of incompatible medications -central venous pressure monitoring lack of usable peripheral IV sites -replacement of multiple peripheral sites for IV access

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