Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
Reported: September 18, 2024 Initiated: May 31, 2024 #Z-2974-2024
Product Description
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
Reason for Recall
There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- 10,240 units
- Distribution
- Worldwide
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX. Recalled by Smiths Medical ASD Inc.. Units affected: 10,240 units.
Why was this product recalled? ▼
There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2024. Severity: Critical. Recall number: Z-2974-2024.
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