Cardinal Health Recalls Kangaroo Connect 1000ml Bag Sets Due to Leak Risk
Cardinal Health 200, LLC is recalling Kangaroo Connect 1000ml Bag Sets because the feeding spike sets may leak at the tube and spike connector interface.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (leaking) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling Kangaroo Connect 1000ml Bag Sets, Non-Sterile, Product Code 77100FD. These are single-use tubing sets used with pumps in the delivery of nutritional feeding product. The recall covers 197,370 units distributed nationwide in the United States.
The recall is being conducted because the feeding spike sets may leak at the interface of the tube and spike connector. The affected products were manufactured between July 1, 2015, and July 20, 2019.
Consumers and healthcare facilities should stop using the affected products and contact Cardinal Health 200, LLC for further instructions or a replacement.
The recalled product
- 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.
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Enteral Feeding
- Hazard
- Affected units
- 197,370
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All lots of products manufactured in the below timespan: July 1
- 2015 and July 20
- 2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Cardinal Health 200, LLC
See all →- HighCardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Packs with Leaking Handpieces
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
FDA (Devices) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
Same hazard · leakage
See all →- SevereDraeger VentStar Resus Neo Neonatal Breathing Circuit Recall
FDA (Devices) · 2026-10-07
- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77522
FDA (Devices) · 2026-08-05
- HighICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk
FDA (Devices) · 2026-07-29
Similar recalls
- HighCardinal Health Recalls Kangaroo Connect ENPlus Spike Sets for Leaking
FDA (Devices) · 2020-06-03
- HighCardinal Health Recalls Kangaroo Epump Safety Screw Spike Sets
FDA (Devices) · 2020-06-03
- HighCardinal Health Recalls Kangaroo Joey Safety Screw Spike Sets
FDA (Devices) · 2020-06-03
- HighCardinal Health Recalls Kangaroo 924 Safety Screw Spike Sets
FDA (Devices) · 2020-06-03
- SevereCardinal Health Enteral Syringes Recalled for Pump Incompatibility
FDA (Devices) · 2024-02-14
- HighCardinal Health Laryngoscopy Packs Recalled for Potential Endotoxin Contamination
FDA (Devices) · 2025-02-19