Device recall: Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
Class II FDA enforcement event 84656. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
The feeding spike sets may leak at the interface of the tube and spike connector.
Class II, in the words of FDA
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
Cardinal Health Inc. started this device recall on 26 Dec 2019. The firm address in the FDA record is in Dublin, OH. FDA put the recall in Class II. FDA event 84656 has 6 product records. The first FDA enforcement report date is 3 Jun 2020. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution.
Recalling firm
Cardinal Health Inc., Dublin, OH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2100-2020 | Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100 | 114,731, 290 total units | Class II | Ongoing | 3 Jun 2020 |
| Z-2101-2020 | Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559 | 114,731, 290 total units | Class II | Ongoing | 3 Jun 2020 |
| Z-2102-2020 | Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD | 114,731, 290 total units | Class II | Ongoing | 3 Jun 2020 |
| Z-2103-2020 | Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Product Code 775100 | 114,731, 290 total units | Class II | Ongoing | 3 Jun 2020 |
| Z-2104-2020 | Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659 | 114,731, 290 total units | Class II | Ongoing | 3 Jun 2020 |
| Z-2105-2020 | Kangaroo 924 Safety Screw Spike Set, Product Code 775759 | 114,731, 290 total units | Class II | Ongoing | 3 Jun 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 6Median of the firm: 3
- Events of the firm on the register
- 12
Other events of the firm
Official channels
- FDA enforcement report Z-2100-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 84656. https://recallregister.com/fda/ii/84656/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution.
- What quantity of product is in FDA event 84656?
- The event has 6 product records. The first record gives this quantity:
114,731, 290 total units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.