Device recall: Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
Class II FDA enforcement event 77282. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The FDA record gives no reason.
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
ConvaTec, Inc started this device recall on 10 May 2017. The firm address in the FDA record is in Greensboro, NC. FDA put the recall in Class II. FDA event 77282 has 18 product records. The first FDA enforcement report date is 14 Jun 2017. The record gives the status Terminated, with the termination date 27 Aug 2021.
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.
CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia,…
Recalling firm
ConvaTec, Inc, Greensboro, NC.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
18 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2228-2017 | Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E; | 816,709 | Class II | Terminated | 14 Jun 2017 |
| Z-2229-2017 | Rebreathing Mask, Reservoir bag, with Tubing, Product Code 104MM | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2230-2017 | Non-Rebreathing Mask, Reservoir Bag, Check Valve, One Side Valve, with Tubing, Product Code 106-E, Product Code 3226MM, and Product Code 9108MM | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2231-2017 | Oxygen Mask, Adult High Concentration Non-Rebreather 2.1 m (7) Oxygen Tubing, Product Code 106MM | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2232-2017 | Oxygen Masks, Elongated (Under Chin), Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, Two Side Valve, Product Code 108-E | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2233-2017 | Non-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7) Oxygen Tubing, Product Code 108MM | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2234-2017 | Non-Rebreather Mask, Reservoir Bag, Check Valve, Two Side Valves, No Tubing, Product Code 226MM | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2235-2017 | Oxygen Masks, Elongated (Under Chin), Adult Med Concentration, No Tubing, FITS-All Conn., Product Code 3104-E | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2236-2017 | Rebreather Oxygen Mask, Adult 7’ (2.1 m) Tubing, Product Code 3104MM, Product Code 9104-E, Product Code PMD06001 | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2237-2017 | Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2238-2017 | Non-Rebreather, Oxygen Mask, Adult 7 (2.1 m) Tubing, Product Code 3108-E, Product Code 3108MM, Product Code 86-106E, Product Code 86-108-E, Product Code LM-86-106, Product Code PMD06002, Product Code PMD06003 | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2239-2017 | Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector, Product Code 3224-E and Product Code 3226-E | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2240-2017 | Oxygen Mask, Elongated (Under the Chin) Pediatric, High Concentration Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, One Side Valve, Product Code 3230-E | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2241-2017 | Non-Rebreathing Mask, Reservoir Bag, Check Valve, Two Side Valves, with Tubing, Product Code 3230MM | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2242-2017 | Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2243-2017 | Non-Rebreather Oxygen Mask, Pediatric with Tubing, Product Code 86-3226E, Product Code PMD06009, Product Code PMD06106 | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2244-2017 | Non-Rebreather Mask w 7’ (2.1 m) “No-Crush” Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA | N/A | Class II | Terminated | 14 Jun 2017 |
| Z-2245-2017 | Pediatric, High Conc. Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-ALL Oxygen Connector 50 Check Valve, One Side Valve, Product Code 9226-E | N/A | Class II | Terminated | 14 Jun 2017 |
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
- 18Median of the firm: 1
- Events of the firm on the register
- 23
Other events of the firm
Official channels
- FDA enforcement report Z-2228-2017The 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 77282. https://recallregister.com/fda/ii/77282/. 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:
CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia,…
- What quantity of product is in FDA event 77282?
- The event has 18 product records. The first record gives this quantity:
816,709
- 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.