Z-0453-2021 Class II Ongoing
FDA device recall Z-0453-2021 was initiated by Cardinal Health 200, LLC on September 22, 2020 and is designated Class II. Reason for recall: The feeding spike sets may leak at the interface of the tube and spike connector. The recall status is ongoing. Affected quantity: 197370.
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2020
- Initiation Date
- September 22, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 197370
Product Description
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.
Reason for Recall
The feeding spike sets may leak at the interface of the tube and spike connector.
Distribution Pattern
US Nationwide distribution.
Code Information
All lots of products manufactured in the below timespan: July 1, 2015 and July 20, 2019