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King Systems Corp. dba Ambu, Inc. FDA Recalls
8 recalls on file across devices, 0 of them Class I and 8 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide pateClass IISep 26, 2024Exceed the limitations to the 510 (k) exemption in 21 CFR 86 |
| KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent Class IISep 26, 2024Exceed the limitations to the 510 (k) exemption in 21 CFR 86 |
| KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Class IISep 26, 2024Exceed the limitations to the 510 (k) exemption in 21 CFR 86 |
| KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent Class IISep 26, 2024Exceed the limitations to the 510 (k) exemption in 21 CFR 86 |
| KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patenClass IISep 26, 2024Exceed the limitations to the 510 (k) exemption in 21 CFR 86 |
| KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Class IISep 26, 2024Exceed the limitations to the 510 (k) exemption in 21 CFR 86 |
| KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent Class IISep 26, 2024Exceed the limitations to the 510 (k) exemption in 21 CFR 86 |
| KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airwayClass IISep 26, 2024Exceed the limitations to the 510 (k) exemption in 21 CFR 86 |