Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non
FDA device recall Z-0015-2013 · posted 2012-10-09 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
- Action taken
- Baxter Healthcare Corp. sent an Urgent Product Recall letter dated September 7, 2012, via first class mail to all affected customers, informing them of the problem with the ball-valve, and instructing them to discontinue use of the affected product and to contact Baxter for instructions to return the affected product.. The customers were also requested to complete the attached customer reply form, confirming their receipt of the letter, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Medical Information Services at Baxter at 1-800-933-0303.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 488,504 units
- Distribution
- Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.
- Date initiated
- 2012-09-07
- Date posted
- 2012-10-09
- Date terminated
- 2017-12-29
- Location
- Round Lake, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BURETROL SOLUTION SETS (K984381) | Baxter Healthcare Corp | 1999-02-19 |