Z-2100-2020Class II

Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100

Name: Z-2100-2020 Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
Creator: Cardinal Health Inc.
Published: 2019-12-26
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-12-26 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health Inc. began a recall of Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100 on 2019-12-26. 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-2100-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-12-26
Posted: 2020-05-22
Recalling firm: Medtronic, Inc.
Product: Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
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 Medical Device Product Advisory letter dated 12/23/19 was sent to customers. 1) INSPECT your inventory for affected product. 2) COMMUNICATE with all personnel that utilize the equipment the risk of leaks at the interface of the tube and spike connector. 3) INSPECT the feeding set for leaks after the pump has been primed and the infusion has started. " 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 " Federal Government800-444-1166 " Distributor800-635-6021 " All other customers888-444-5440 For questions related to the notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: [email protected] or call 800-292-9332.
Quantity in commerce: 114,731, 290 total units
Distribution: Worldwide distribution.
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2100-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2100-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-22
Z-2101-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-22
Z-2102-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-22
Z-2103-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-22
Z-2104-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-22
Z-2105-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-06-03	2020-05-22

Product code LZH

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)