Z-2181-2025 Class I Ongoing

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 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611000 5 SPUR II Adult Resuscitator, Pop-off open 40 ,w/PEEP Valve 20, Adult, Catalog Number: 524611001 6 SPUR II Adult Resuscitator w/PEEP Valve 20, Adult, Catalog Number: 524611011 7 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611031 8 SPUR II Adult Resuscitator w/Pressure Limiting Valve, Adult, Catalog Number: 524611047 9 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 524611051 10 SPUR II Pediatric Resuscitator w/10 O2 tube & Manometer, Catalog Number: 530200016 11 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530212000 12 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530212001 13 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213000 14 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213001 15 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213011 16 SPUR II Pediatric Resuscitator w/Manometer, Pediatric, Catalog Number: 530213030 17 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213031 18 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530213048 19 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530214000 20 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530613000 21 SPUR II Pediatric Resuscitator w/Manometer & PEEP Valve 20, Pediatric, Catalog Number: 530613031 22 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530613071 23 SPUR II Pediatric Resuscitator w/PEEP Valve 20,Manometer & CO2 Detector, Pediatric, Catalog Number: 530613831 24 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530614017 25 SPUR II Pediatric Resuscitator w/Manometer, Pediatric, Catalog Number: 530614030 26 SPUR II Pediatric Resuscitator w/CO2 Detector, Pediatric, Catalog Number: 530614800 27 SPUR II Pediatric Resuscitator, INF& TOD W/Manometer, Pediatric, Catalog Number: 530615030 28 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 530619031 29 SPUR II Pediatric Resuscitator w/Expiratory Filter, Manometer PEEP Valve, Pediatric, Catalog Number: 531600051 30 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613000 31 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613001 32 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613010 33 SPUR¿ II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613031 34 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531613047 35 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number:531613051 36 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531614026 37 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number: 531638000 38 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611051E 39 SPUR II Pediatric Resuscitator, Single Patient Use Resuscitator, Pediatric, Catalog Number:530213000B The Ambu SPUR II Resuscitator is a single patient use resuscitator intended for pulmonary resus

Potential for the manometer port being blocked rendering the manometer non-functional.

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; Lot Numbers: 2000015969, 2000016252. 10. Catalog Number: 530200016; UDI Number: 05707480149773; Lot Numbers: 2000014933, 2000015857. 11. Catalog Number: 530212000; UDI Number: 05707480152353; Lot Numbers: 1001113557. 12. Catalog Number: 530212001; UDI Number: 05707480149797; Lot Numbers: 2000016408. 13. Catalog Number: 530213000; UDI Number: 05707480152377; Lot Numbers: 1001110299, 1001113558, 1001118767, 1001106634. 14. Catalog Number: 530213001; UDI Number: 05707480152391; Lot Numbers: 1001106635. 15. Catalog Number: 530213011; UDI Number: 05707480152438; Lot Numbers: 1001118768. 16. Catalog Number: 530213030; UDI Number: 05707480149858; Lot Numbers: 2000016409. 17. Catalog Number: 530213031; UDI Number: 05707480152452; Lot Numbers: 1001113560, 1001118769. 18. Catalog Number: 530213048; UDI Number: 05707480154159; Lot Numbers: 2000016529, 2000016410. 19. Catalog Number: 530214000; UDI Number: 05707480152490; Lot Numbers: 1001106636, 1001113561. 20. Catalog Number: 530613000; UDI Number: 05707480152612; Lot Numbers: 1001110301, 1001121455, 1001106637, 1001118771. 21. Catalog Number: 530613031; UDI Number: 05707480150212; Lot Numbers: 2000015889. 22. Catalog Number: 530613071; UDI Number: 05707480150298; Lot Numbers: 2000015574. 23. Catalog Number: 530613831; UDI Number: 05707480150373; Lot Numbers: 2000015179, 2000015726, 2000015891. 24. Catalog Number: 530614017; UDI Number: 05707480150397; Lot Numbers: 2000015440. 25. Catalog Number: 530614030; UDI Number: 05707480150410; Lot Numbers: 2000014938, 2000015299. 26. Catalog Number: 530614800; UDI Number: 05707480150434; Lot Numbers: 2000015098. 27. Catalog Number: 530615030; UDI Number: 05707480150472; Lot Numbers: 2000015893. 28. Catalog Number: 530619031; UDI Number: 05707480150595; Lot Numbers: 2000016761. 29. Catalog Number: 531600051; UDI Number: 05707480163441; Lot Numbers: 2000015181, 2000015577. 30. Catalog Number: 531613000; UDI Number: 05707480152773; Lot Numbers: 1001118773, 1001121460, 1001106640. 31. Catalog Number: 531613001; UDI Number: 05707480152797; Lot Numbers: 1001106641, 1001110305, 1001113567, 1001118774. 32. Catalog Number: 531613010; UDI Number: 05707480152810; Lot Numbers: 1001113568. 33. Catalog Number: 531613031; UDI Number: 05707480150717; Lot Numbers: 2000015182, 2000015731, 2000015896, 2000016112, 2000016263. 34. Catalog Number: 531613047; UDI Number: 05707480150755; Lot Numbers: 2000015444, 2000015580, 2000015897, 2000015982. 35. Catalog Number: 531613051; UDI Number: 05707480154470; Lot Numbers: 2000016825. 36. Catalog Number: 531614026; UDI Number: 05707480150854; Lot Numbers: 2000016265, 2000016612. 37. Catalog Number: 531638000; UDI Number: 05707480150878; Lot Numbers: 2000015184, 2000015583. 38. Catalog Number: 523611051E; UDI Number: 05707480154135; Lot Numbers: 2000015292, 2000015559, 2000016401. 39. Catalog Number: 530213000B; UDI Number: 05707480153534; Lot Numbers: 1001113559