Ambu SPUR II Resuscitators Recalled for Blocked Manometer Port
Ambu Inc. is recalling 87,156 SPUR II Resuscitator units because the manometer port may become blocked, rendering the manometer non-functional. The recall affects models distributed nationwide and in Canada.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4 per the regulatory rubric. No deaths, hospitalizations, or reported injuries are documented in the source text.
Plain-English summary
Ambu Inc. is recalling multiple catalog numbers of the Ambu SPUR II Resuscitator, a single-patient use resuscitator intended for pulmonary resuscitation. The recall affects both adult and pediatric models with various configurations, distributed nationwide in the United States and in Canada.
The defect is that the manometer port may become blocked, rendering the manometer non-functional. The manometer is a monitoring component used during resuscitation procedures.
Healthcare facilities and providers currently using affected models should discontinue use and contact Ambu Inc. for instructions regarding replacement or repair. The recall encompasses approximately 87,156 units with specific lot numbers and catalog numbers available through the FDA website or from the manufacturer.
The recalled product
- Product
- Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4
- Manufacturer
- Ambu Inc.
- Hazard
- manometer-blockage
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1. Catalog Number: 523211000
- UDI Number: 05707480152193
- Lot Numbers: 1001113554
- 1001118764. 2. Catalog Number: 523611051
- UDI Number: 05707480149513
- Lot Numbers: 2000015874. 3. Catalog Number: 523611057
- UDI Number: 05707480038688
- Lot Numbers: 2000015876. 4. Catalog Number: 524611000
- UDI Number: 05707480152278
- Lot Numbers: 1001110297. 5. Catalog Number: 524611001
- UDI Number: 05707480149698
- Lot Numbers: 2000015881. 6. Catalog Number: 524611011
- UDI Number: 05707480149711
- Lot Numbers: 2000015882. 7. Catalog Number: 524611031
- UDI Number: 05707480149735
- Lot Numbers: 2000015884
- 2000015968. 8. Catalog Number: 524611047
- UDI Number: 05707480149759
- Lot Numbers: 2000016102. 9. Catalog Number: 524611051
- UDI Number: 05707480154395
Distribution
Distributed nationwide across the United States.
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