Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
Enforcement
- Recall Number
- Z-1604-2013
- Event ID
- 65365
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Baxter Healthcare Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 3, 2013
- Initiation Date
- June 7, 2013
- Classification Date
- June 27, 2013
- Termination Date
- June 4, 2014
- Address
- Route 120 And Wilson Rd, Round Lake, IL, 60073-9799, United States
Description
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
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 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
Distributed Nationwide and in Puerto Rico.
3,255,096 total