Z-1576-2018Class I
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow
Jaeger Medical GmbH / initiated 2017-04-27 / Terminated / root cause: design
Vyaire Medical began a recall of AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices... on . FDA classified it as Class I and gives the reason as "The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1576-2018
- Classification
- Class I
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Jaeger Medical GmbH
- Product
- AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
- Product code
- OEV Cardiopulmonary Resuscitation Aid Kit
- Reason for recall
- The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
- Root cause tag
- design
- FDA root cause
- Component design/selection
- Action
- The firm, Vyaire Medical, sent an "URGENT RECALL NOTICE" letter on 04/27/2017 and again on 06/08/2017 for the expansion of the recall to its Customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect current inventory on-hand and immediately perform a 1OO% physical inventory of the product to identify and be removed; complete and return the Customer Response Form by Fax to: (312) 949.0972 or email to:[email protected].; destroy all affected product in accordance with your facility's destruction protocol; and for replacements, contact your distributor Armstrong Medical direct at (800)323.4220 x129. For any additional questions and support concerning this voluntary recall, please contact Customer Advocacy Analyst at (224) 706.6829 or email: [email protected].
- Quantity in commerce
- 1,140 units
- Distribution
- Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
- Product codes and lots
- Part Number: 2K8080BR. Lots: 0000890354, 0000890352, 0000940373, 0000979974, 0000994500
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1547-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1548-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1549-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1550-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1551-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1552-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1553-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1554-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1555-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1556-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1557-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1558-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1559-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1560-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1561-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1562-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1563-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1564-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1565-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1566-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1567-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1568-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1569-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1570-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1571-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1572-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1573-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1574-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1575-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1576-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1577-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1578-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1579-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1580-2018 | Class I | Terminated | Voluntary: Firm initiated | ||
| Z-1581-2018 | Class I | Terminated | Voluntary: Firm initiated |
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