Ambu Inc.: 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

Hazard

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

Details from the source

Reason for recall: Potential for the manometer port being blocked rendering the manometer non-functional. Distribution: Worldwide distribution - US Nationwide and the country of Canada. Quantity: 87,156 units Lot/code info: 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: 100111356

UPC codes

05707480152193, 05707480149513, 05707480038688, 05707480152278, 05707480149698, 05707480149711, 05707480149735, 05707480149759, 05707480154395, 05707480149773, 05707480152353, 05707480149797, 05707480152377, 05707480152391, 05707480152438, 05707480149858, 05707480152452, 05707480154159, 05707480152490, 05707480152612, 05707480150212, 05707480150298, 05707480150373, 05707480150397, 05707480150410, 05707480150434, 05707480150472, 05707480150595, 05707480163441, 05707480152773, 05707480152797, 05707480152810, 05707480150717, 05707480150755, 05707480154470, 05707480150854, 05707480150878, 05707480154135, 05707480153534

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.