Recall Z-0076-2015— Arrow International Inc

Name: FDA recall Z-0076-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-18

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2014-09-18, terminated 2014-12-02. It names one FDA 510(k) clearance: K862056. Product: Multi-Lumen Central Venous Catheterization Kit. Reason: Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2014-09-18
Terminated: 2014-12-02
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

Multi-Lumen Central Venous Catheterization Kit

Reason for recall

Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date.

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