GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dial
FDA device recall Z-0370-2017 · posted 2016-11-08 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Potential presence of particulate matter on the blood side of the dialyzer
- Action taken
- Baxter sent an Urgent Product Recall letter dated October 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: I. Locate and remove all affected product lots from their facility. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. 3. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or scanned email. For questions contact Baxter Product Surveillance at 800-437-5176.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KDL
- Quantity affected
- 22,656 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Canada and Mexico.
- Date initiated
- 2016-10-12
- Date posted
- 2016-11-08
- Date terminated
- 2017-08-19
- Location
- Deerfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GAMBRO POLYFLUX HD-C4 CAPILLARY DIALYZER/FILTER FOR SINGLE USE (K060195) | Gambro Renal Products | 2006-04-24 |