Device recall: 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box
Class III FDA enforcement event 89453. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
CellEra LLC started this device recall on 15 Dec 2021. The firm address in the FDA record is in Monroe, OH. FDA put the recall in Class III. FDA event 89453 has 5 product records. The first FDA enforcement report date is 23 Mar 2022. The record gives the status Terminated, with the termination date 16 Oct 2023.
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
CellEra LLC, Monroe, OH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0801-2022 | 20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box | 30,000 ea | Class III | Terminated | 23 Mar 2022 |
| Z-0802-2022 | 20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box | 9200 ea | Class III | Terminated | 23 Mar 2022 |
| Z-0803-2022 | 20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box | 4400 ea | Class III | Terminated | 23 Mar 2022 |
| Z-0804-2022 | 20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box | 17850 ea | Class III | Terminated | 23 Mar 2022 |
| Z-0805-2022 | 20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box | 11770 ea | Class III | Terminated | 23 Mar 2022 |
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 III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class III
- 3%
- Product records in this event
- 5Median of the firm: 5
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Sep 2016 | VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144 Event 83281 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0801-2022The 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 89453. https://recallregister.com/fda/iii/89453/. 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:
US Nationwide distribution.
- What quantity of product is in FDA event 89453?
- The event has 5 product records. The first record gives this quantity:
30,000 ea
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 3% of the 900 device events that started in 2021 are in Class III.