BD Medical Extension Sets Recalled for Potential Sterilization Defects
BD Switzerland is recalling 93,700 intravascular extension sets because they may not have received adequate sterilization processing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (inadequate sterilization of medical devices) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
BD Switzerland SARL is recalling 93,700 units of intravascular administration and extension sets, including the 60 In Non-DEHP Minibore Extension Set, MaxPlus Ext Set w/Needleless and Y-Site, and 9 IN Extension Set w/Max Y. The recall is due to a potential defect where the products may not have received adequate sterilization processing.
The affected products were distributed in the United States to Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, and Washington, as well as to Canada.
Healthcare providers and consumers should stop using the affected extension sets immediately. The specific lot numbers for the recalled items are 26025260, 26035455, and 26055528.
The recalled product
- Product
- 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Intravascular Administration Set and…
- Manufacturer
- BD SWITZERLAND SARL
- Hazard
- Affected units
- 93,700
Distribution
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