Recall Z-2256-2017— Arrow International Inc

Name: FDA recall Z-2256-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-20

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2017-03-20, terminated 2018-12-18. It names one FDA 510(k) clearance: K002507. Product: Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. Reason: Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products..

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2017-03-20
Terminated: 2018-12-18
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K002507 — TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORTArrow Intl., Inc.·cleared 2001-03-21

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 Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling

Reason for recall

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

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