Device recall: Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow…
Class II FDA enforcement event 77289. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
SPAG-2 unit nebulizers from Lot J0571670RA were tested at Next Breath for particle sizing under the validated method, NB-TM-261, In November 2016. The particle size specification set in NB-SPEC-039 for Dv10, Dv50, & Dv90 are a mean value of no more than 3.0¿m, 5.5 m, and 15¿m respectively. Initial testing of the nebulizers yielded four units that delivered particle sizes that did not meet the…
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
Valeant Pharmacueticals International started this device recall on 13 Mar 2017. The firm address in the FDA record is in Rochester, NY. FDA put the recall in Class II. FDA event 77289 has 1 product record. The first FDA enforcement report date is 24 Jan 2018. The record gives the status Terminated, with the termination date 18 Jun 2019.
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 & Canada
Recalling firm
Valeant Pharmacueticals International, Rochester, NY.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0384-2018 | Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a pressurized gas (air or blended oxygen) and uses a nebulizer to generate a fine aerosol of hydrated Virazole. --- CDRH… | 418 SPAG-2 and 808 Nebulizers | Class II | Terminated | 24 Jan 2018 |
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 2017
- 1,091
- Share of these events in Class II
- 93%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Jan 2016 | Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, C | Device | Class II | 1 |
| 21 Sep 2015 | Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A ne | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0384-2018The 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 77289. https://recallregister.com/fda/ii/77289/. 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 & Canada
- What quantity of product is in FDA event 77289?
- The FDA record gives this quantity:
418 SPAG-2 and 808 Nebulizers
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2017 have the same class?
- 93% of the 1,091 device events that started in 2017 are in Class II.