Recall Z-1603-2013 ยท MEB Pump, Infusion, Elastomeric
Baxter Healthcare Corp.
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
| Date | Jun 27, 2013 (initiated Jun 7, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 3,255,096 total |
| Distribution | Distributed Nationwide and in Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943664 | INTERMATE XLV ELASTOMERIC INFUSION SYSTEM Baxter Healthcare Corp, Nov 3, 1994 |