Kangaroo Enteral Feeding Spike Sets (2020-09-23)
- Starting date:
- September 23, 2020
- Posting date:
- October 23, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-74163
Last updated:
2020-10-22
Affected Products
A. Kangaroo ePump ENPlus Spike with 1000 mL Flush Bag
B. Kangaroo ePump ENPlus Spike Set
C. Kangaroo Joey Pump Feeding Safety Screw Spike Set DEHP-Free PVC
D. Kangaroo Joey ENPlus Spike Set
E. Kangaroo Joey Safety Screw Spike with 1000 mL Flush Bag
F. Kangaroo Connect ENPlus Spike Set, Non-Sterile
G. Kangaroo Connect Bag Set, Non-Sterile
Reason
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. Cardinal has updated this notification to include all unexpired lots manufactured to date. In addition, Cardinal has added two additional product codes of Kangaroo Connect 500 mL and 1000 mL Bag Sets to the product correction notice. Cardinal continues 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. Cardinal Health Canada is not aware of any injury reports with respect of the use of affected product in the canadian market as of September 22nd 2020.
Affected products
A. Kangaroo ePump ENPlus Spike with 1000 mL Flush Bag
Lot or serial number
All lots.
Model or catalog number
775100
Companies
- Manufacturer
-
Cardinal Health 200, LLC (carrying on the patient recovery business from Covidien LLC)
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
B. Kangaroo ePump ENPlus Spike Set
Lot or serial number
All lots.
Model or catalog number
775659
Companies
- Manufacturer
-
Cardinal Health 200, LLC (carrying on the patient recovery business from Covidien LLC)
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
C. Kangaroo Joey Pump Feeding Safety Screw Spike Set DEHP-Free PVC
Lot or serial number
All lots.
Model or catalog number
775759
Companies
- Manufacturer
-
Cardinal Health 200, LLC (carrying on the patient recovery business from Covidien LLC)
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
D. Kangaroo Joey ENPlus Spike Set
Lot or serial number
All lots.
Model or catalog number
765559
Companies
- Manufacturer
-
Cardinal Health 200, LLC (carrying on the patient recovery business from Covidien LLC)
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
E. Kangaroo Joey Safety Screw Spike with 1000 mL Flush Bag
Lot or serial number
All lots.
Model or catalog number
765100
Companies
- Manufacturer
-
Cardinal Health 200, LLC (carrying on the patient recovery business from Covidien LLC)
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
F. Kangaroo Connect ENPlus Spike Set, Non-Sterile
Lot or serial number
All lots.
Model or catalog number
77000FD
Companies
- Manufacturer
-
Cardinal Health 200, LLC (carrying on the patient recovery business from Covidien LLC)
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES
G. Kangaroo Connect Bag Set, Non-Sterile
Lot or serial number
Lots lower than 19201XXXX.
Model or catalog number
77100FD
77500FD
Companies
- Manufacturer
-
Cardinal Health 200, LLC (carrying on the patient recovery business from Covidien LLC)
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES