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