Baxter Sabraset 6060 Administration Set with Pre-attached 100 mL Bag and Cassette, product code 560500-100; Manufactured
FDA device recall Z-1087-05 · posted 2005-08-06 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- The inlet and outlet lines of the administration set may be reversed, which would result in reverse flow.
- Action taken
- Baxter sent Urgent Device Correction letters dated 5/4/05 to their customers, to the attention of the Director of Nursing, via first class mail on the same date. The accounts were informed of the one complaint of reverse assembly of the administration set, and were provided with diagrams showing the configuration of a correct assembly and an incorrect assembly of the sets. The accounts were instructed to inspect the sets carefully before use to assure correct assembly. The accounts were requested to destroy any misassembled sets found and complete the certificate of destruction enclosed with the letter, faxing it back to Baxter at 847-270-5457 to receive credit for the destroyed sets.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 13,229 units
- Distribution
- Nationwide and internationally to Australia, Belgium, Canada and Japan.
- Date initiated
- 2005-05-04
- Date posted
- 2005-08-06
- Date terminated
- 2006-07-21
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351 (K002679) | Baxter Healthcare Corp | 2000-09-18 |