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Recall Observatory FDA recall evidence

Device product

Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional feeding product.

Z-0453-2021

September 22, 2020

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 86575
Status
Ongoing
Classification
Class II
Quantity
197370
Official record key
device-enforcement:Z-0453-2021

Official wording

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

Code information: All lots of products manufactured in the below timespan: July 1, 2015 and July 20, 2019

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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