Recall Z-0452-2021— Cardinal Health 200, LLC

Name: FDA recall Z-0452-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-22

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2020-09-22. It names one FDA 510(k) clearance: K153074. Product: Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.. Reason: The feeding spike sets may leak at the interface of the tube and spike connector..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Ongoing
Initiated: 2020-09-22
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K153074 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect PortalCovidien·cleared 2016-07-06

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

Kangaroo Connect 500ml Bag Set, Non-Sterile, Product Code 77500FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.

Reason for recall

The feeding spike sets may leak at the interface of the tube and spike connector.

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