Reported Mar 14, 2018 · Terminated
StrykeFlow 2 System, labeled sterile. Includes the following
Stryker Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Corporation · 5900 Optical Ct · San Jose, CA · 95138-1400
Is this the product you have?
StrykeFlow 2 System, labeled sterile. Includes the following
3 of 3 products
| Model / number | Product as published |
|---|---|
0250070500 | STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 ( ) |
0250070505 | STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip ( ) |
0250070520 | STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip ( ) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR |
- Amount recalled
- 60,753 units total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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