Recall Z-2080-2014— Stryker Endoscopy

Name: FDA recall Z-2080-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-20

Class II · Terminated

Class II FDA medical device recall by Stryker Endoscopy, initiated 2014-06-20, terminated 2014-10-15. It names one FDA 510(k) clearance: K042457. Product: 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.. Reason: 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..

Recalling firm: Stryker Endoscopy
Classification: Class II
Status: Terminated
Initiated: 2014-06-20
Terminated: 2014-10-15
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K042457 — URO PROW.O.M. World of Medicine AG·cleared 2004-10-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.