Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.

FDA device recall Z-1603-2013 · 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

MEB

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

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