IV Start Kit Recall Receives FDA Class I Rating Over Fungus in Skin Prep Applicators
核心洞察
The FDA posted a Class I classification on Sept. 14 for an AVID Medical (搜索) Halyard IV start kit containing a skin prep applicator contaminated with a fungus.
The recall covers 288 units of lot 1658437 distributed in Nebraska, tracing to BD (搜索) ChloraPrep Clear (搜索) 1 mL applicators from lot 4032183.
No injuries or deaths have been reported, and the FDA lists the cause as packaging process control at the applicator manufacturer.
The FDA posted a Class I classification on Sept. 14 for a recall of the Halyard IV START KIT NON-STERILE, reference number KRIV26-02, lot 1658437, made by AVID Medical (搜索), a subsidiary of Owens & Minor (搜索). The FDA's recall record lists 288 units in commerce, distributed in Nebraska, and the recall remains open. Class I is the agency's most serious recall category, used when there is a reasonable chance of serious health problems or death. The contamination has been known since June; the classification is new.
The problem traces upstream to a component made by BD (搜索). The FDA record states the kits contain BD ChloraPrep Clear (搜索) 1 mL and FREPP Clear (搜索) 1.5 mL applicators contaminated with the fungus Aspergillus penicillioides (搜索), and lists the FDA-determined cause as packaging process control. AVID identified the affected component as ChloraPrep Clear 1 mL applicators from BD lot 4032183. BD announced a voluntary nationwide recall of two applicator lots to the consumer level in June, saying the lots shipped to distributors and hospitals between March and June 2024 and that it had received no adverse event reports. Because some applicators had already been packed into prepackaged kits, each kit maker issued its own notice. Medline first told customers on June 12 to label affected kits with a sticker instructing staff to remove and discard the applicator, then changed course on Aug. 11 to tell customers to destroy the entire kit. AVID sent its first notice on July 14 and issued an urgent recall update on Aug. 18 asking customers to quarantine affected products, discard the entire kit, and return response forms by Aug. 28.
The FDA says skin prep products contaminated with Aspergillus penicillioides (搜索) may cause widespread infection, sepsis (搜索), and death. If the fungus enters the bloodstream during IV catheter placement, the catheter would likely need removal and another procedure; an infected surgical site may require medical and surgical treatment plus long-term antifungal medication. No harm has been reported, and Medline had reported no serious injuries or deaths as of Aug. 17. Supply managers, pharmacy staff, and infection prevention teams should check inventory against recalled lot numbers and follow manufacturers' instructions. Patients who develop fever, chills, redness, swelling, drainage, or worsening pain at a recent procedure site should contact the clinician who performed it, and immunocompromised patients such as transplant recipients face the highest risk. The FDA has not published a total count of affected kits across all makers, has not classified every related recall, and has not said whether more lots will be added.
Source: MedicalDaily