Recall Z-0835-2018— Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Corporation, initiated 2017-11-17, terminated 2024-01-29. It names 2 FDA 510(k) clearances: K954726, K934094. 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: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates..
- Recalling firm
- Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-17
- Terminated
- 2024-01-29
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K954726 — STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)
- K934094 — STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.