CLASS II Device recall · Reported 3 Jul 2013 · FDA Enforcement Report

Intermate Infusion Pump recalled by Baxter Healthcare

Baxter Healthcare is recalling Intermate Infusion Pump, distributed nationwide in the US. The recall was initiated on 7 Jun 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Codes: 2C1064K Lot Codes: 10F007 10F077 10H075 10J097 10K076 10K112 10M062 Expiration Date: 06/30/13

Quantity recalled3,255,096 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1603-2013
FDA event ID: 65365
Recalling firm: Baxter Healthcare, Round Lake, IL
Classification: Class II
Status: Terminated
Recall initiated: 7 Jun 2013
FDA classified: 27 Jun 2013
Reported: 3 Jul 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Infusion Pumps

Timeline

7 Jun 2013	Recall initiated by company
27 Jun 2013	Classified by FDA	+20 days
3 Jul 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Distributed Nationwide and in Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Is Intermate Infusion Pump recalled?

Yes. Baxter Healthcare recalled Intermate Infusion Pump on 7 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-1603-2013.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Distributed Nationwide and in Puerto Rico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS I	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled	Baxter Healthcare	Other	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
1 Jul 2026Device	CLASS II	Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled	Boston Scientific	Packaging Defects	Nationwide