Baxter Interlink System Minivolume Extension Set, product code 1C8483; 18'', 1.3 mL Vol., with 0.22 Micron Downstream Fi
FDA device recall Z-1101-05 · posted 2005-08-06 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Leaks and disconnection between the bifurcated Y-site and the set tubing may occur and result in underdelivery of medication, blood loss, and a breach of the sterile fluid pathway.
- Action taken
- Baxter sent Urgent Product Recall letters dated 7/6/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the complaints of leaks and disconnection between the bifurcated Y-site and the set tubing, resulting in the possible under delivery of medication, blood loss and a breach of the sterile fluid pathway. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 3,072 sets
- Distribution
- Arizona, Georgia, Illinois, Michigan, Ohio, Pennsylvania, South Carolina and Texas.
- Date initiated
- 2005-07-06
- Date posted
- 2005-08-06
- Date terminated
- 2007-01-31
- 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 |
|---|---|---|
| RADIATION STERILIZED ADMIN. SET (K811078) | Travenol Laboratories, S.A. | 1981-07-02 |