FDA recall Z-0835-2018

Stryker Corporation · Class II · device

Product

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 (Model 0250070520) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR

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.

Key facts

Status: Terminated
Initiation date: 2017-11-17
Report date: 2018-03-14
Termination date: 2024-01-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0835-2018