Stryker StrykeFlow suction irrigator may leak solution into the handpiece
The Stryker StrykeFlow Disposable Suction/Irrigator is being recalled because irrigation solution may leak into the handpiece and battery pack, causing it to malfunction.
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: Risk-of-harm product: an in-use malfunction of a surgical suction and irrigation device, with no injury reported in the source.
Plain-English summary
The Stryker StrykeFlow Disposable Suction/Irrigator without Disposable Tip, REF 0250070500, UDI 07613327061390, is being recalled. The source does not state a quantity.
According to the manufacturer, following complaints there is the potential that irrigation solution may leak into the handpiece and battery pack, causing it to malfunction. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was worldwide, including nationwide in the United States. The devices are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the REF and UDI above and follow the instructions issued by Stryker.
The recalled product
- Product
- Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
- Manufacturer
- Stryker Corporation
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: 07613327061390
Distribution
Part of a larger recall action
This product is one of 2 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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