Device recall: Seattle PAP Plus, MP02260
Class I FDA enforcement event 92049. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Draeger Medical, Inc. started this device recall on 17 Apr 2023. The firm address in the FDA record is in Telford, PA. FDA put the recall in Class I. FDA event 92049 has 22 product records. The first FDA enforcement report date is 24 May 2023. The record gives the status Terminated, with the termination date 3 Sep 2024.
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.
Domestic: US Nationwide Distribution.
Recalling firm
Draeger Medical, Inc., Telford, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
22 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1439-2023 | Seattle PAP Plus, MP02260 | 32,050 untis | Class I | Terminated | 24 May 2023 |
| Z-1440-2023 | VentStar Basic (P)180, MP00351 | 325 units | Class I | Terminated | 24 May 2023 |
| Z-1441-2023 | VentStar Basic (P)250, MP00352 | 200 units | Class I | Terminated | 24 May 2023 |
| Z-1442-2023 | VentStar Watertrap (P) 180, MP00361 | 50 units | Class I | Terminated | 24 May 2023 |
| Z-1443-2023 | VentStar Watertrap (P) 180 w/oLL, MP00362 | 25 units | Class I | Terminated | 24 May 2023 |
| Z-1444-2023 | VentStar Anesthesia WT (P)180, MP00374 | 130 units | Class I | Terminated | 24 May 2023 |
| Z-1445-2023 | VentStar breathing bag Set (P) 110, MP00384 | 25 units | Class I | Terminated | 24 May 2023 |
| Z-1446-2023 | ID Circuit Basic (P) 180, MP01340 | 25 units | Class I | Terminated | 24 May 2023 |
| Z-1447-2023 | VentStar Anesthesia (N) 180, MP00333 | N/A | Class I | Terminated | 24 May 2023 |
| Z-1448-2023 | VentStar Basic (N) 180, MP00353 | 1,725 units | Class I | Terminated | 24 May 2023 |
| Z-1449-2023 | VentStar Watertrap (N) 180, MP00363 | 125 units | Class I | Terminated | 24 May 2023 |
| Z-1450-2023 | VentStar Bag Set (N) 110, MP00383 | 375 units | Class I | Terminated | 24 May 2023 |
| Z-1451-2023 | VentStar Coax (P) 150, MP00379 | 280 units | Class I | Terminated | 24 May 2023 |
| Z-1452-2023 | Anesthesia Circuit Kit Coax 1, MP02730 | 200,900 units | Class I | Terminated | 24 May 2023 |
| Z-1453-2023 | Anesthesia Circuit Kit Coax 3, MP02732 | 329,294 units | Class I | Terminated | 24 May 2023 |
| Z-1454-2023 | Ventstar Coax, MP03373 | 2,380 units | Class I | Terminated | 24 May 2023 |
| Z-1455-2023 | Ventstar Coax 180, MP03374 | 18,160 units | Class I | Terminated | 24 May 2023 |
| Z-1456-2023 | ID Coax 180, MP03375 | 20 units | Class I | Terminated | 24 May 2023 |
| Z-1457-2023 | Ventstar Coax 230, MP03376 | 40 units | Class I | Terminated | 24 May 2023 |
| Z-1458-2023 | Anesthesia Set Coax 180, MP03384 | 20 units | Class I | Terminated | 24 May 2023 |
| Z-1459-2023 | Set2Go Ventilation 12 (A), MP07968 | 500 units | Class I | Terminated | 24 May 2023 |
| Z-1460-2023 | Anesthesia Circuit Kit Coax HEPA, MP17102 | 720 units | Class I | Terminated | 24 May 2023 |
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 I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class I
- 10%
- Product records in this event
- 22Median of the firm: 1
- Events of the firm on the register
- 30
Other events of the firm
Official channels
- FDA enforcement report Z-1439-2023The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 92049. https://recallregister.com/fda/i/92049/. 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:
Domestic: US Nationwide Distribution.
- What quantity of product is in FDA event 92049?
- The event has 22 product records. The first record gives this quantity:
32,050 untis
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 10% of the 917 device events that started in 2023 are in Class I.