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Infusion Pumps

🏥 Medical Devices • 4,262 recalls

Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.

Synthes (USA) Products

Class I - Dangerous

The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.

Oct 7, 2015 Infusion Pumps Nationwide View Details →

TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is designed for use in operating rooms, medical treatment rooms, intensive care units, or any area of a medical facility that requires a ceiling mounted device to supply power, medical gases, and data-communication services. TELETOM is designed to be used in rooms that have been constructed to meet National Fire Protection Association.

Berchtold

Class I - Dangerous

During the use of the TELETOM Series 4 & 6 there is potential for the controls and brakes not to work properly due to fluid intrusion within the control switches and/or the control board assembly.

Sep 23, 2015 Infusion Pumps Nationwide View Details →

MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

Beckman Coulter

Class I - Dangerous

Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.

Sep 10, 2015 Infusion Pumps Nationwide View Details →

Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.

Beckman Coulter

Class I - Dangerous

Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.

Aug 31, 2015 Infusion Pumps Nationwide View Details →

MICroSTREP plus 2 Panel, Part No. B1027-202 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

Beckman Coulter

Class I - Dangerous

Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.

Sep 10, 2015 Infusion Pumps Nationwide View Details →

Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek¿/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.

STERILMED

Class I - Dangerous

Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices.

Aug 24, 2015 Infusion Pumps Nationwide View Details →

P/N: 9734856, SCREWDRIVER, 9734856, SOLERA STD MAST; P/N: 9734857, SCREWDRIVER, 9734857, SOLERA RDN MAST; P/N: 9734279, SCREWDRIVER 9734279 SOLERA STANDARD; and P/N: 9734373, SCREWDRIVER 9734373 SOLERA REDUCTION. The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.

Medtronic Navigation

Class I - Dangerous

Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.

Sep 14, 2015 Infusion Pumps Nationwide View Details →

Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.

Biosense Webster

Class I - Dangerous

Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.

Sep 10, 2015 Infusion Pumps Nationwide View Details →

P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN; P/N: 9735025, DRIVER 9735025 SOLERA 5.5/6.0 RMAS; P/N: 9735026, DRIVER 9735026 SOLERA 5.5/6.0 RMAS CAN; P/N: 9735027,DRIVER 9735027 SOLERA 5.5/6.0 FAS/SAS. The Medtronic Navigated Solera Screwdrivers are reusable devices that are designed for use in spine surgery to assist in the placement of screws during the surgery, using a Medtronic computer-assisted surgery system.

Medtronic Navigation

Class I - Dangerous

Specific use conditions can increase the possibility of a screwdriver tip deforming or breaking during surgery.

Sep 14, 2015 Infusion Pumps Nationwide View Details →

Terumo Custom Cardiovascular Procedure Kit Tubing Pack P/N: 66041-1 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed.

Terumo Cardiovascular Systems

Class I - Dangerous

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Aug 24, 2015 Infusion Pumps Nationwide View Details →

Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE P/N: 7928-03 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Terumo Cardiovascular Systems

Class I - Dangerous

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Aug 24, 2015 Infusion Pumps Nationwide View Details →

Terumo Custom Cardiovascular Procedure Kit X-Coated Pediatric Pack P/N: 74039-02 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Terumo Cardiovascular Systems

Class I - Dangerous

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Aug 24, 2015 Infusion Pumps Nationwide View Details →

Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75185 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Terumo Cardiovascular Systems

Class I - Dangerous

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Aug 24, 2015 Infusion Pumps Nationwide View Details →

Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack P/N: 74077-01 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Terumo Cardiovascular Systems

Class I - Dangerous

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Aug 24, 2015 Infusion Pumps Nationwide View Details →

Terumo Custom Cardiovascular Procedure Kit X-Coated PED/Adult Main Pack P/N: 75529 Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed

Terumo Cardiovascular Systems

Class I - Dangerous

Custom Cardiovascular Procedure Kits contain recalled component Medivators HPH700 High Performance Hemoconcentrators

Aug 24, 2015 Infusion Pumps Nationwide View Details →

ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a sterile disposable plastic rod used to advance extracorporeal suture knots during minimally invasive cardiac surgery.

Edwards Lifesciences

Class I - Dangerous

The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or splitting of the suture could occur, which could compromise the integrity of the suture knot.

Aug 26, 2015 Infusion Pumps Nationwide View Details →
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