Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

475 results found for infusion pump Page 14 of 19
Hospira Inc.
Class II Terminated
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion Syst...
Reason: May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. ...
Z-0361-2017 November 16, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16027. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion Syst...
Reason: May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. ...
Z-0362-2017 November 16, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027
Reason: Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Sup...
Z-0354-2017 November 9, 2016 Lake Forest, IL
Unomedical As
Class II Terminated
AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80...
Reason: Tubing detachment
Z-0357-2017 November 9, 2016 Roskilde
Unomedical As
Class II Terminated
Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Deta...
Reason: Tubing detachment
Z-0356-2017 November 9, 2016 Roskilde
Unomedical As
Class II Terminated
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; Su...
Reason: Tubing detachment
Z-0360-2017 November 9, 2016 Roskilde
Hospira Inc.
Class II Terminated
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026
Reason: Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Sup...
Z-0353-2017 November 9, 2016 Lake Forest, IL
Unomedical As
Class II Terminated
Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusio...
Reason: Tubing detachment
Z-0355-2017 November 9, 2016 Roskilde
Unomedical As
Class II Terminated
Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Confor...
Reason: Tubing detachment
Z-0358-2017 November 9, 2016 Roskilde
Unomedical As
Class II Terminated
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm,...
Reason: Tubing detachment
Z-0359-2017 November 9, 2016 Roskilde
Hospira Inc.
Class II Terminated
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, n...
Reason: Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior ...
Z-0305-2017 November 2, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nut...
Reason: Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior ...
Z-0306-2017 November 2, 2016 Lake Forest, IL
EKOS Corporation
Class II Terminated
The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold inf...
Reason: Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.
Z-2890-2016 October 5, 2016 Bothell, WA
Zyno Medical LLC
Class II Terminated
Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product Usage: Zyno Medical Administration Set is a device used to adm...
Reason: Administration Set potential filter leaking
Z-2896-2016 October 5, 2016 Natick, MA
Zyno Medical LLC
Class II Terminated
Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) Product Usage: Zy...
Reason: Administration Set potential filter leaking
Z-2895-2016 October 5, 2016 Natick, MA
Zyno Medical LLC
Class II Terminated
Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to ad...
Reason: Administration Set potential filter leaking
Z-2894-2016 October 5, 2016 Natick, MA
Hospira Inc., A Pfizer Company
Class II Terminated
Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Manageme...
Reason: Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed i...
Z-2790-2016 September 21, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum o...
Reason: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Z-2728-2016 September 14, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectr...
Reason: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Z-2722-2016 September 14, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across t...
Reason: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Z-2727-2016 September 14, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinic...
Reason: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Z-2724-2016 September 14, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clini...
Reason: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Z-2725-2016 September 14, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinic...
Reason: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Z-2723-2016 September 14, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across ...
Reason: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Z-2730-2016 September 14, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across t...
Reason: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.
Z-2726-2016 September 14, 2016 Lake Forest, IL