Baxter Recalls Filter Used with Repeater Pharmacy Pump
Baxter Healthcare Corporation has issued a letter recalling "all unexpired lots of the 50mm 0.2 Micron Filter" because the filter devices might not actually contain the "filter membrane layer." Filter devices from these lots were distributed as early as August 22, 2013, the letter states.
The filter devices have the Baxter product code H93835 and, according to the company's website, are an accessory to the Repeater Pharmacy Pump, originally made by Baxa Corporation. Baxa was bought by Baxter in 2011.
Baxter's letter, dated August 26, states that the filter device "is a bacteria and particulate filter for aqueous solutions used during the compounding of solutions." The letter itself does not mention the Repeater Pharmacy Pump.
Without the filter membrane layer in the filter device, the letter states, "any bacteria present in unsterile solution may pass through to the compounded preparation" and "any particulate matter present in the unsterile solution would pass through to the compounded product."
The company said in its letter, directed to pharmacy directors, that no reports of adverse events have been associated with the filter device's potentially "missing" filter membrane layer.
Facilities with unexpired H93835 filter devices should remove them and call Baxter Healthcare Center for Service, at 888-229-0001, to arrange for return and credit, the company said. The service center answers calls 7 a.m. to 6 p.m. CT Monday through Friday but will be closed on Labor Day.
Pharmacists at facilities that use Baxter's H93835 filter device, advised ASHP's Bona Benjamin, Director of Medication-Use Quality Improvement, should retrieve any solution that was compounded using one of the potentially defective units.
Further, she stated, pharmacists should work with their hospital leadership — including risk management and infection control departments — to develop a plan for notifying providers and providing care for patients who recently received potentially contaminated solution.
Solutions prepared using the potentially defective filter device may contain particulates, Benjamin explained. Also, those solutions — if prepared from nonsterile starting components, exposed to air not meeting International Organization for Standardization class 5 cleanliness conditions, or prepared under other conditions described in USP Chapter <797> medium- or high-risk categories — are at risk for microbial contamination.