Medical Device Recalls

Hospira Inc.

Class II Terminated

LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the ad...

Reason: Hospira has received reports of customers experiencing air-in-line alarms related to administration sets that have a drip chamber with a ball valve. Preliminary investigation findi...

Z-1751-2013 July 24, 2013 Lake Forest, IL

Codman & Shurtleff, Inc.

Class I Terminated

MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal deliv...

Reason: Miscalibrated Fill Level Sensor may affect dosing level

Z-1691-2013 July 24, 2013 Raynham, MA

Medtronic MiniMed

Class I Terminated

Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.

Reason: Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur...

Z-1668-2013 July 17, 2013 Northridge, CA

Baxter Healthcare Corp.

Class II Terminated

Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication thera...

Reason: There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicate...

Z-1677-2013 July 17, 2013 Deerfield, IL

Baxter Healthcare Corp.

Class II Terminated

Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication thera...

Reason: There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicate...

Z-1678-2013 July 17, 2013 Deerfield, IL

Baxter Healthcare Corp.

Class II Terminated

Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication thera...

Reason: There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicate...

Z-1679-2013 July 17, 2013 Deerfield, IL

Medtronic Neuromodulation

Class I Terminated

Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and deli...

Reason: Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal...

Z-1579-2013 July 3, 2013 Minneapolis, MN

Medtronic Neuromodulation

Class I Terminated

Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. Product Usa...

Reason: Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the primin...

Z-1571-2013 July 3, 2013 Minneapolis, MN

Medtronic Neuromodulation

Class I Terminated

Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with ...

Reason: The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the...

Z-1573-2013 July 3, 2013 Minneapolis, MN

Baxter Healthcare Corp.

Class II Terminated

Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Dev...

Reason: Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the ...

Z-1609-2013 July 3, 2013 Round Lake, IL

Medtronic Neuromodulation

Class I Terminated

Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. The pump is part ...

Reason: Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal...

Z-1580-2013 July 3, 2013 Minneapolis, MN

Greatbatch Medical

Class II Terminated

Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14...

Reason: Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product. Some units were manufactured with an un...

Z-1608-2013 July 3, 2013 Minneapolis, MN

Baxter Healthcare Corp.

Class II Terminated

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 a...

Z-1604-2013 July 3, 2013 Round Lake, IL

Baxter Healthcare Corp.

Class II Terminated

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 a...

Z-1603-2013 July 3, 2013 Round Lake, IL

Medtronic Neuromodulation

Class I Terminated

Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion sys...

Reason: Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the primin...

Z-1570-2013 July 3, 2013 Minneapolis, MN

Symbios Medical Products, LLC

Class I Terminated

Part 510180 Disposable Single Infusion Pump, ... Elastomeric Pump 300 mL, 2mL/hr,... found in : GoPump Kit 510201-BP, 5 fenestrated catheter & BIOPATCH; Go Pump Kit 510349-BP, Epidural Catheter, B...