Dive Brief:
- Smiths Medical has recalled portable ventilators for two problems that can cause patients not to receive enough oxygen, adding to the firm’s ongoing safety issues this year with multiple product types.
- The Food and Drug Administration recently posted two Class I recalls of Smiths’ PneuPAC ParaPAC Plus P300 and P310 ventilators. Class I is the agency’s most severe recall classification.
- One recall, which described a loose patient outlet connector, was associated with reports of one injury and one death. The other described problems with the tidal volume knob moving out of position, which could result in patients receiving too little or too much ventilation. No injuries or deaths were reported with the second recall.
Dive Insight:
Smiths, acquired by ICU Medical in 2022, has faced multiple quality problems in recent years. The company received a warning letter in 2021, and the FDA has posted seven Class I recalls involving the company in 2024.
Smiths’ ParaPAC ventilators are the focus of two recalls posted by the FDA in late September. The devices provide ventilation support for patients during emergencies such as accident scenes and during medical transport, including airplanes and helicopters. They are used for adults, children and infants.
Smiths sent a letter to customers in May warning that the patient outlet connector could become loose or detached. More than 14,000 devices are affected by the recall, according to FDA database entries.
The devices are still on the market, but Smiths said customers should check the connector before each use and remove any devices where it moves or feels loose for repairs. The company also recommended monitoring blood oxygen and carbon dioxide levels independently and having an alternative means of ventilation available.
Smiths also issued a second recall of the ventilators in May, this time for problems with the tidal volume knob for the devices, which is used to adjust the amount of air delivered to patients with each breath. When set at high or low levels, the knob may move away from the original setting. If that happens, Smiths recommends removing it from use until it can be repaired. The recall includes more than 12,000 units, according to FDA database entries.
Smiths recalled thousands of ventilators earlier this year for another problem linked to eight serious injuries, in which the devices could intermittently provide “continuous positive gas flow instead of the intended cycling like a human breath.” The firm also recalled defective tracheostomy tubes connected to one death and 35 serious injuries.
Vivek Jain, CEO of parent company ICU Medical, told investors last month that resolving Smiths’ quality problems has been more challenging than expected.
On Sept. 30, ICU Medical named Daniel Woolson its new president. Woolson will take the leadership post after serving as the company’s general manager of infusion systems since 2017.