Recall Z-0370-2017— Baxter Healthcare Corp.
Class II · Terminated
Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2016-10-12, terminated 2017-08-19. It names one FDA 510(k) clearance: K060195. Product: GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.. Reason: Potential presence of particulate matter on the blood side of the dialyzer.
- Recalling firm
- Baxter Healthcare Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-12
- Terminated
- 2017-08-19
- Firm location
- Deerfield, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
Reason for recall
Potential presence of particulate matter on the blood side of the dialyzer
Data sourced from openFDA. This site is unofficial and independent of the FDA.