Device recall: Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model…
Class II FDA enforcement event 99764. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
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
AVID Medical, Inc. started this device recall on 22 Jul 2026. The firm address in the FDA record is in Toano, VA. FDA put the recall in Class II. FDA event 99764 has 2 product records. The first FDA enforcement report date is 30 Sep 2026. The record gives the status Ongoing. 187 of the 677 device events that started in 2026 have more product records. The median device event of 2026 has 1 product record.
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.
US Nationwide distribution.
Recalling firm
AVID Medical, Inc., Toano, VA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-3260-2026 | Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-02 | 816 kits (17 cases) | Class II | Ongoing | 30 Sep 2026 |
| Z-3261-2026 | Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL Applicator. Kit Model Number: KRIV26-01 | 192 kits (4 cases) | Class II | Ongoing | 30 Sep 2026 |
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 2026
- 677
- Share of these events in Class II
- 87%
- Product records in this event
- 2Median of the firm: 3
- Events of the firm on the register
- 27
Other events of the firm
Official channels
- FDA enforcement report Z-3260-2026The 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 99764. https://recallregister.com/fda/ii/99764/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 27 Oct 2026
- Newest FDA report date on the register
- 21 Oct 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:
US Nationwide distribution.
- What quantity of product is in FDA event 99764?
- The event has 2 product records. The first record gives this quantity:
816 kits (17 cases)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 87% of the 677 device events that started in 2026 are in Class II.