Stryker StrykeFlow Disposable Suction/Irrigator Malfunction Recall
Stryker is recalling StrykeFlow disposable suction/irrigators because irrigation solution may leak into the handpiece and battery pack, causing potential device malfunction.
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: This is an FDA Class II recall of a surgical device where the hazard is theoretical (potential malfunction) with no reported injuries or hospitalizations. It qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling its StrykeFlow REF: 0250070520/2 Disposable Suction/Irrigator with Disposable Tip (UDI 07613327061369) due to reports of a potential malfunction hazard.
Complaints have been received indicating that irrigation solution may leak into the handpiece and battery pack, which could cause the device to malfunction during clinical use.
The recalled product was distributed worldwide, including throughout the United States in all states and territories, as well as in Argentina, Philippines, Singapore, China, Japan, Korea, and Canada.
Healthcare facilities and providers using this product should discontinue use of affected units and contact Stryker Corporation or the FDA for information regarding replacement or repair options.
The recalled product
- Product
- Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
- Manufacturer
- Stryker Corporation
- Hazard
- device-malfunction
- liquid-intrusion
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 07613327061369
Distribution
Distributed nationwide across the United States.
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