A Medical Device Daily
Baxter Healthcare (Deerfield, Illinois) said it expanded the recall of its Colleague and Flo-Gard drug infusion pumps first reported in July (Medical Device Daily , July 27, 2007) to include an additional 986 devices.
The company last month recalled 534 of the pumps after it discovered some devices sent to its Phoenix service center for repair or maintenance may have been returned to customers without work being performed on them. Three employees involved in falsifying electrical safety data were dismissed, Baxter said.
No serious injuries or patient deaths have been linked to the recall, the company said.
The expansion of the recall represents pumps serviced by all three employees previously mentioned who have been dismissed. Baxter said its investigation of the matter is continuing. The company will continue to provide updates and instructions to users regarding the service documentation recall on www.baxter.com.
The company has informed all customers to contact Baxter and return affected pumps for repeat inspection and servicing and will provide loaner pumps free of charge.
The FDA in July gave the recall a Class I classification because of the potential for serious injury or death should a device malfunction.
Baxter in April began correcting defects in existing Colleague infusion pumps, after receiving approval from U.S. regulators, following the 2005 seizure by authorities of 6,000 pumps thought to have a defect that could cause them to shut down or deliver the wrong amount of medication.
There are about 275,000 Colleague pumps in use in hospitals worldwide, with more than 200,000 of those in the U.S, according to the company. The company must complete a quality audit process with regulators before it can sell any new Colleague pumps. The company has not set a timeline for when it may resume sales of the product but has said it does not expect any sales in 2007.