Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2080-2014 — 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.

U.S. FDA — Device Enforcement · United States · 2014-06-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2080-2014
Date of alert
2014-06-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Endoscopy
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
0250070505
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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