Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV acc
FDA device recall Z-0845-05 · posted 2005-05-17 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.
- Action taken
- Recall letters dated 2/28/05 were sent to the direct accounts via first class mail on the same date to the attention of the Director of Nursing. The accounts were informed of the increase in reports of ClearLink valve occlusion, requested to examine their inventory for the affected lots of product, and call Baxter Healthcare Center for Service at 1-888-229-001 to return the affected product for credit. The letters included a copy of the Technical Letter revised 5/4/04, outlining the correct preparation and use ClearLink valve product, including detecting valve re-knits.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 1,171,116 sets
- Distribution
- Nationwide, including Puerto Rico and American Samoa, and internationally to Canada, Panama, Australia, New Zealand and Venezuela.
- Date initiated
- 2005-02-28
- Date posted
- 2005-05-17
- Date terminated
- 2007-02-08
- Location
- Round Lake, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE (K003225) | Baxter Healthcare Corp | 2000-10-19 |
| BURETROL SOLUTION SETS (K984381) | Baxter Healthcare Corp | 1999-02-19 |
| STOPCOCK MANIFOLD GANGS (K962581) | Baxter Healthcare Corp | 1996-08-28 |
| CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET (K961225) | Baxter Healthcare Corp | 1996-06-21 |
| LOW PLASTICIZER ADMINISTRATION SETS (K791496) | Travenol Laboratories, S.A. | 1980-04-08 |