5 medical device recalls, corrections

Here are five of the latest recalls and corrections reported to the FDA: 

1. Ambu recalls SPUR II resuscitators due to blocked manometer port 

Ambu is recalling specific lots of its SPUR II manual resuscitators because a blocked manometer port renders the manometer nonfunctional. The defect can prevent clinicians from monitoring ventilation pressure, which could potentially cause barotrauma, collapsed lungs and death. Customers were instructed to identify and discard the affected devices. No injuries or deaths have been reported. 

2. Hamilton Medical recalls breathing circuits over cracked inner tubes 

Hamilton Medical is recalling two lots of its coaxial breathing circuit sets after discovering cracks in the inner blue limb caused by a defective tube cutting blade. This could result in rebreathing of exhaled gases and carbon dioxide buildup, potentially leading to respiratory acidosis, organ dysfunction or death. Facilities have been advised to stop using affected units and return them to the manufacturer. No adverse events have been reported. 

3. Integra LifeSciences recalls extended tip applicators over sterility risk 

Integra LifeSciences is removing all lots, expired and unexpired, of its extended tip applicators due to concerns of incomplete sterilization and high endotoxin levels. Use of the devices could lead to infection, inflammation or death. Customers were instructed to quarantine unexpired products and discard expired ones. No injuries or deaths have been reported. 

4. ICU Medical issues correction for Plum Duo infusion system 

ICU Medical issued a correction for its Plum Duo infusion system due to software issues that could cause the device to become unresponsive during use and delaying or interrupting critical therapy. Healthcare providers were advised to quarantine the affected devices. No injuries or deaths have been reported. 

5. Abbott Medical recalls HeartMate MPU power cords due to disconnection risk 

Abbott Medical is recalling AC power cords used with its HeartRate mobile power unit because the cords may not lock securely into place. This could result in unintentional disconnection, loss of power to heart pumps and potential fatal consequences like hemodynamic instability or multi-organ failure. No injuries or deaths have been reported.  

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