Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Perit
FDA device recall Z-2132-2012 · posted 2012-08-02 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Renal Div
- Reason for recall
- Baxter discovered that a Baxter technical service representative was providing incorrect instructions for inspection of solution bags for a blocked frangible prior to connection to the Automated PD Set with Cassette.
- Action taken
- Baxter Healthcare Corp. sent "Important Product Information" letters dated July 6, 2012 to the affected home patients and their clinicians, via first class mail on the same date. The letter identified the product, problem and actions to be taken. The customers were instructed to refer to the Extraneal and/or Dineal package insert, Directions For Use - Preparation for Administration and the HomeChoice APD Systems At-Home Guide for proper procedures to connect to a solution line. Customers are instructed to retain a copy of the letter. The customers were also requested to complete the attached customer reply form and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Global Technical Services, Renal Technical Support at 1-800-553-6898, option 1, 24 hours a day. For questions regarding this recall call 1-800-422-9837.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FKX
- Quantity affected
- N/A
- Distribution
- Nationwide Distribution includingArizona, California, Ohio, Pennsylvania and Virginia.
- Date initiated
- 2012-07-06
- Date posted
- 2012-08-02
- Date terminated
- 2012-10-15
- Location
- Waukegan, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL (K923065) | Baxter Healthcare Corp | 1994-03-04 |