Ambu® SPUR®II Adult and Pediatric Resuscitator
Brand(s)
Summary
Discard the affected products and contact the manufacturer for a refund or replacement.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Ambu® SPUR®II Adult Resuscitator | 1001113554 | 523211000 |
| Ambu® SPUR®II Adult Resuscitator | 1001118764 | 523211000 |
| Ambu® SPUR®II Adult Resuscitator | 1001110297 | 524611000 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001110299 | 530213000 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001106636 | 530214000 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001113558 | 530213000 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001106635 | 530213001 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001106637 | 530613000 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001118767 | 530213000 |
| Ambu® SPUR®II Pediatric Resuscitator | 2000015889 | 530613031 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001113560 | 530213031 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001106634 | 530213000 |
| Ambu® SPUR®II Pediatric Resuscitator | 1001118769 | 530213031 |
Issue
A total of 5 complaints have been received for SPUR® II concerning the manometer port being blocked, rendering the attached manometer non-functional. None of the complaints involved patients. For the defect devices, no indication of pressure control is possible via the manometer port and the attached manometer. Although SPUR® II's ability to deliver oxygen remains unaffected, the defect increases the risk of barotrauma if the pressure limiting valve is overridden. Additionally, the defect increases the risk of delayed procedure (s1), potentially leading to temporary hypoxia, due to possible user uncertainty of operating a device with noon-functional manometer.
Recall start date: July 14, 2025
Additional information
Details
Ambu A/S
Baltorpbakken 13, Ballerup, Denmark, 2750
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