Reported Jul 30, 2014 · Terminated
Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction…
Stryker Endoscopy
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 Endoscopy · 5900 Optical Ct · San Jose, CA · 95138-1400
Is this the product you have?
- Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. for endoscopic use.
- Lot codes and dates
- P/N 0250070505
- Lot numbers
14021FG213337FG213343FG213347FG214007FG214016FG2
- Amount recalled
- 496 boxes (6 tips per box)
Where it was sold
- Nationwide
Why it was recalled
Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.
This product could cause temporary or reversible health problems — stop using it.
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