Z-1457-2023Class I
Ventstar Coax 230, MP03376
Draeger, Inc. / initiated 2023-04-17 / Terminated / root cause: manufacturing process
Draeger Medical, Inc. began a recall of Ventstar Coax 230, MP03376 on . FDA classified it as Class I and gives the reason as "Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1457-2023
- Classification
- Class I
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Draeger, Inc.
- Product
- Ventstar Coax 230, MP03376
- Product code
- BZO Set, Tubing And Support, Ventilator (W Harness)
- Reason for recall
- Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- The firm distributed recall notifications to consignees via FedEx starting on 4/17/2023. Consignees are instructed to immediately stop use of affected devices, inspect current stock, and quarantine any affected devices to prevent use. Alternative therapy for patients should be instituted as soon as possible and ensure all users of affected devices within consignee organizations are aware of the recall, with copies being forwarded if devices were further distributed. To replace or return unused products, consignees are to call Draeger Customer Success between 8:00 AM - 6:00 PM EST, Monday thru Friday, at 1-800-437-2437 (option 2, then option 1), or via email at [email protected]. A Return Materials Authorization and pre-paid shipping label will be provided upon request. Any additional questions regarding the recall communication may be directed to Mr. Michael Kelhart between the hours of 8:00 AM - 4:30 PM by phone at 267-664-1131 or by email at [email protected].
- Quantity in commerce
- 40 units
- Distribution
- Domestic: US Nationwide Distribution.
- Product codes and lots
- UDI-DI: 04048675545613; All lots.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1439-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1440-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1441-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1442-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1443-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1444-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1445-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1446-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1447-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1448-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1449-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1450-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1451-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1452-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1453-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1454-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1455-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1456-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1457-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1458-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1459-2023 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1460-2023 | Class I | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.