Smith & Nephew Recalls High Flow Irrigation Extender for Separation Risk
Smith & Nephew is recalling 203 High Flow Irrigation Extenders because the device body may separate during surgery, potentially obstructing visualization and causing fluid leakage.
What this means for you
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 is classified as FDA Class II. The hazard involves a device malfunction that obstructs visualization and causes fluid leakage during surgery, which is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Smith & Nephew, Inc., Endoscopy Div. is recalling 203 units of the High Flow Irrigation Extender (Part Number 72201021). These arthroscopic accessories are indicated for use in access of the joint capsule. The recall covers units distributed worldwide, including the United States and Japan.
The recall is being issued because, during arthroscopic surgery, the body of the irrigation extender may separate when the scope is moved inside the cannula. This separation can potentially obstruct visualization and cause leakage of the irrigation fluid. The source text notes that the device is removed and a back-up device is used to complete the surgery.
The recall includes units distributed in the US states of AL, AR, CA, FL, GA, ID, IL, KS, MA, MI, MO, NC, TN, TX, and AK, as well as in Japan. The source text does not specify specific lot numbers or expiration dates, but lists multiple code numbers associated with the affected units.
The recalled product
- Product
- High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.
- Manufacturer
- Smith & Nephew, Inc., Endoscopy Div.
- Affected units
- 203
Distribution
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