Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of medications.
FDA device recall Z-1605-2013 · posted 2013-06-27 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
- Action taken
- An Urgent Product Recall notification was sent to all affected consignees on 06/13/2013. The letter states the affected products, problem description, hazard involved and actions to be taken by customer/user, with contact information. The letter was accompanied by a Customer Reply Form and a table of Affected Product List. The recall notification instructs customers to segregate affected product and contact Baxter for instructions for return of product.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 3,255,096 total
- Distribution
- Distributed Nationwide and in Puerto Rico.
- Date initiated
- 2013-06-07
- Date posted
- 2013-06-27
- Date terminated
- 2014-06-04
- 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 |
|---|---|---|
| LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH. (K910425) | Baxter Healthcare Corp | 1991-04-01 |