Z-0453-2021Class II

Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD -

Name: Z-0453-2021 Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD -
Creator: Cardinal Health 200, LLC
Published: 2020-09-22
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-09-22 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of Kangaroo Connect 1000ml Bag Set, Non-Sterile, Product Code 77100FD - Product Usage: single-use tubing sets used with pumps in the delivery of nutritional... on 2020-09-22. FDA classified it as Class II and gives the reason as "The feeding spike sets may leak at the interface of the tube and spike connector". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0453-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-22
Posted: 2020-11-13
Recalling firm: Medtronic, Inc.
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.
Product code: LZH Pump, Infusion, Enteral
Reason for recall: The feeding spike sets may leak at the interface of the tube and spike connector.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A Product Correction Notice dated 922/20 was sent to customers. Cardinal Health had previously notified customers of a Medical Device Product Advisory in December 2019 due to the potential risk of leaks with Kangaroo enteral feeding spike sets*. The purpose of this communication is to inform you that we have updated this notification to include all unexpired lots manufactured to date, in addition, we have added two additional product codes of Kangaroo Connect 500ml and 1000ml bag sets to the product correction notice. The Product Correction Notice is for all unexpired lots of the below Kangaroo enteral feeding spike sets and all lots of Kangaroo Connect 500ml and 1000ml bag sets manufactured between July 1, 2015 and July 20, 2019. We continue to receive complaints of leaking at the interface of the tube and spike connector, in addition to complaints of leaking due to PVC tubing disconnecting from the cassette in Connect bag sets. 1) INSPECT your inventory for affected product. 2) COMMUNICATE with all personnel that utilize these feeding sets the risk of leaks at the interface of the tube and spike connector in Kangaroo enteral feeding spike sets and the risk of PVC tubing disconnecting from the cassette in Kangaroo Connect Bag Sets causing leaking. 3) INSPECT the feeding set for leaks after the pump has been primed, after the infusion has started, and throughout the infusion process. " If a leak is detected the feeding set must be discarded and a new feeding set must be obtained. Inspect the new feeding set for leaks in the same manner. 4) NOTIFY any customers to whom you may have distributed or forwarded affected product about this product advisory. 5) RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648 or email to [email protected], whether or not you have affected product. Please contact the Customer Service group for any questions related to this action: " Hospital800-964-5227
Quantity in commerce: 197370
Distribution: US Nationwide distribution.
Product codes and lots: All lots of products manufactured in the below timespan: July 1, 2015 and July 20, 2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0453-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0452-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-25	2020-11-13
Z-0453-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-11-25	2020-11-13

Product code LZH

K153074Class IIKangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect PortalCovidien / cleared 2016-07-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)