FDA announces recall of Integra applicators due to sanitation risk
The U.S. Food and Drug Administration (FDA) said it is aware of an urgent recall issued by Integra LifeSciences for a line of extended tip applicators—single-use, sterile devices used during surgeries. The company said the tips may not have been properly sterilized, which could put patients at increased risk for a serious, possibly fatal infection.
No injuries or fatalities have been reported to the FDA. However, given the serious threat to patient safety, the recall has been designated a Class I, the most serious type.
The extended tip applicators are commonly found in operating rooms across the country, and any from recalled lots will need to be quarantined immediately to ensure they are not used.
What is being recalled?
The devices come in two sizes, 8 cm and 15 cm. Integra said both are subject to the recall. See the chart below for details, including Unique Device Identifiers and catalog numbers.
Next steps
If the expiration date has passed on any of the extended tip applicators, they should be discarded. All other products linked to recalled lots will need to be returned to Integra for a refund or replacement.
Customers are asked to contact the company at [email protected] or by phone at 1-800-654-2873 to return the necessary acknowledgement form along with any recalled devices.
Both Integra and the FDA ask that this notice be shared to assist in removing the tip applicators from supply houses and clinical care settings. It can be found by clicking here.
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