Z-1604-2013Class II

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

Name: Z-1604-2013 Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications
Creator: Baxter Healthcare Corp.
Published: 2013-06-07
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2013-06-07 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications on 2013-06-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1604-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-07
Posted: 2013-06-27
Terminated: 2014-06-04
Recalling firm: Baxter Healthcare Corporation
Product: Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
Product code: FRN Pump, Infusion
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 3,255,096 total
Distribution: Distributed Nationwide and in Puerto Rico.
Product codes and lots: Product Codes: 2C1730K, 2C1732K, 2C1734K, 2C1740K, 2C1743K, 2C1744K Lot Codes: 10F009 10F049 10F053 10F057 10F095 10J006 10J079 10K077 10M067 10F004 10F015 10G016 10G017 10G018 10G019 10G053 10G054 10H007 10H008 10H009 10H049 10H050 10H051 10H079 10H080 10H081 10H108 10J002 10J009 10J011 10J012 10J077 10J078 10J083 10K009 10K010 10K011 10K012 10K014 10K018 10K070 10K071 10K072 10M015 10M061 10M066 10M071 10M073 10M074 10M082 10F010 10F011 10F079 10G021 10G022 10G023 10H010 10H025 10H026 10H047 10J003 10J004 10J005 10J080 10J081 10J082 10J093 10K016 10K017 10K019 10M008 10M010 10M075 10M078 10M080 10M081 10H083 10M065 10F051 10F073 10G039 10G040 10J007 10J008 10J109 10K007 10K057 10K106 10M064 10M070 10F005 10F006 10F052 6/19/2010 6/22/2010 6/23/2010 8/13/2010 8/23/2010 8/30/2010 9/3/2010 9/30/2010 10/4/2010 10/21/2010 10/26/2010 11/4/2010 11/15/2010 11/24/2010 Expiration Date: 06/30/13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1604-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1600-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1601-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1602-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1603-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1604-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1605-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1606-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27

Product code FRN

K910425Class IILarge Volume Elastomeric Infusion Device Attach.Baxter Healthcare Corp / cleared 1991-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)