Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1603-2013

June 07, 2013

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 65365
Status
Terminated
Classification
Class II
Quantity
3,255,096 total
Official record key
device-enforcement:Z-1603-2013

Official wording

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.

Code information: Product Codes: 2C1064K Lot Codes: 10F007 10F077 10H075 10J097 10K076 10K112 10M062 Expiration Date: 06/30/13

Distribution pattern: Distributed Nationwide and in Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.