| 2025-06-20 |
Class II
|
Ongoing |
Z-2276-2025 |
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. |
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Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, … |
| 2025-06-20 |
Class II
|
Ongoing |
Z-2275-2025 |
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. |
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Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, … |
| 2025-06-17 |
Class I
|
Ongoing |
Z-2102-2025 |
i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngosc… |
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Potential for faulty devices as a result of depleted batteries. |
| 2022-08-29 |
Class II
|
Terminated |
Z-0096-2023 |
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000 |
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Printing error on the device, size 3 Solus Standard laryngeal mask airway has been incorrectly marked with size 4 information (includes the number 4 as a size i… |
| 2020-11-11 |
Class II
|
Terminated |
Z-0753-2021 |
Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multi… |
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The device was assembled with the incorrect exhalation port which can cause gas leakage. |