Recall Z-0723-2019— Arrow International Inc

Name: FDA recall Z-0723-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-14

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2018-11-14, terminated 2020-06-04. It names one FDA 510(k) clearance: K862056. Product: Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products. Reason: The lidstock states the incorrect priming volume and flow rates..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2018-11-14
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 CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products

Reason for recall

The lidstock states the incorrect priming volume and flow rates.

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