Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile device with 3 injection sites, v
FDA device recall Z-0502-2011 · posted 2010-12-01 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- If the manifolds are connected in series, there may be a risk of the manifolds loosening or disconnecting at the luer connection between them.
- Action taken
- Baxter sent an "Urgent Device Correction" letter dated October 20, 2010, via first class mail to the direct accounts, to the attention of the Director of Nursing and the Director of Materials Management, informing them that there may be a risk of the manifolds loosening or disconnecting at the luer connection between them. The loosening or disconnection can result in an interruption of therapy, potentially resulting in patient injury and death. The accounts were requested to place the notification where the inventory of affected product is dispensed, so that users are made aware of the procedures to follow: "If these devices are connected in series, and the luer connector is tightened, do not twist the manifolds. This may lead to loosening or disconnection, which may cause a leak. Additionally, Baxter recommends checking all connections before starting and during infusion therapy." The accounts were 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. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.
- Root cause
- Other
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 752,965 units in US and all lots in Japan
- Distribution
- Worldwide Distribution -- United States and Japan.
- Date initiated
- 2010-10-21
- Date posted
- 2010-12-01
- Date terminated
- 2011-10-16
- 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 |
|---|---|---|
| INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS (K970438) | Baxter Healthcare Corp | 1997-04-02 |