Stryker Corporation: StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRI

Is my product affected?

StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (

• UPC 07613327061390
• UPC 07613327061406
• UPC 07613327061369

Check against the official notice below — it lists the full affected range.

What happened

Stryker Corporation is recalling 60,753 units of its StrykeFlow 2 System suction irrigator devices that are labeled as sterile. These devices, which include three models (0250070500, 0250070505, and 0250070520), were distributed domestically within the United States as well as internationally to Australia and Mexico. The recall affects specific lot numbers of each model, which are identified by lot codes ranging from 17275FG2 through 17302FG2.

The reason for the recall is that routine bioburden testing found that certain lots contained higher levels of microorganisms than Stryker's internal acceptable rates. The source document does not specify a remedy for consumers who possess affected units.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

Details from the source

Reason for recall: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. Distribution: Distributed domestically to . Distributed internationally to Australia and Mexico. Quantity: 60,753 units total Lot/code info: a. Model 0250070500, Product Code GCJ, UDI 07613327061390, Lot No. 17275FG2, 17276FG2, 17277FG2, 17278FG2, 17279FG2, 17280FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17290FG2, 17291FG2, 17292FG2, 17293FG2, 17294FG2, 17297FG2, 17299FG2, 17301FG2); 0250070505, 0250070520; b. Model 0250070505, Product Code GCX, UDI 07613327061406, Lot No. 17294FG2; c. Model 0250070520, Product Code GCX, UDI 07613327061369, Lot No. 17282FG2, 17283FG2, 17286FG2, 17289FG2, 17290FG2, 17292FG2, 17293FG2, 17294FG2, 17296FG2, 17297FG2, 17298FG2, 17299FG2, 17300FG2, 17301FG2, 17302FG2

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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