Recall Z-1603-2013— Baxter Healthcare Corp.

Name: FDA recall Z-1603-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-07

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2013-06-07, terminated 2014-06-04. It names one FDA 510(k) clearance: K943664. Product: Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.. 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..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2013-06-07
Terminated: 2014-06-04
Firm location: Round Lake, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K943664 — INTERMATE XLV ELASTOMERIC INFUSION SYSTEMBaxter Healthcare Corp·cleared 1994-11-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.