NCPS Patient Safety Alert and Patient Safety Advisory Development Process
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
| February 3, 2010 | Alert
|
Fresenius HemaClip used during dialysis AL10-05 |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
| December 14, 2009 | Alert
|
Possible blood contamination in hemodialysis machines AL10-04 |
| October 6, 2009 | Alert
|
Attempted hanging from a door in a locked mental health unit AL10-03 |
| October 1, 2009 | Alert
|
Glucose Monitoring Test Strips that utilize Glucose Dehydrogenase Pyrroloquinoline Quinone (GDH-PQQ) methodology may give falsely elevated glucose results AL10-01 |
| September 2, 2009 | Alert
|
Operable exterior windows in locked inpatient mental health units AL09-25 |
| August 6, 2009 | Alert
|
Medtronic SynchroMed II Implantable Drug Infusion Pump; Models: 8637-20 and 8637-40 AL09-24 |
| July 10, 2009 | Advisory
|
Alarms on bedside physiological monitors AD09-09 |
| June 16, 2009 | Alert
|
Philips IntelliVue G1/G5 Anesthesia Gas Modules:
Model Numbers M1013A and M1019A and
Dräger Apollo Anesthesia Machines and Multigas Monitor:
Model SCIO AL09-23 |
| June 8, 2009 | Alert
|
Physician Advisory issued by Medtronic Inc. on subsets of:
Kappa 600/700/900 series dual chamber and single chamber
pacemakers and Sigma 100/200/300 series dual chamber and
single chamber cardiac pacemakers AL09-22 |
| May 4, 2009 | Alert
|
Arjo Carendo Shower Chair Model BIB 2003-01 or BIB2003-01KT AL09-21 |
| April 22, 2009 | Alert |
Transvaginal Placement of Surgical Mesh AL09-20 |
| April 3, 2009 | Alert |
CPRS – Changing Medication Schedule may Leave Incorrect
Medication Administration Times AL09-19 |
| March 31, 2009 | Alert |
Product Recall: Watson Pharmaceutical Propafenone HCL tablet
Lot # 112680A, with expiration date of July 31, 2010. AL09-18 |
| March 24, 2009 | Alert |
AEDPlus Public Access Automated External Defibrillators (AEDs), manufactured by Zoll. AL09-17 |
| March 10, 2009 | Alert |
Product Recall:Duragesic® 50 mcg/h (Fentanyl Transdermal System) CII (patch)
National Drug code (NDC) 50458-034-05, Lot #0817239 and Sandoz Inc. 50
mcg/hr patches Lot number 0816851 Replaces and supersedes Patient Safety Alert AL09-08, issued January 13, 2009 AL09-08 Amendment |
| March 5, 2009 | Alert |
Cylinder Valve Explodes from Oxygen Cylinder supplied with
Rotarex/Ceodeux Post Type Cylinder Valve AL09-16 |
| March 3, 2009 | Alert |
Medication Safety- Insulin U-500 Safety Enhancements AL09-15 |
| February 20, 2009 | Alert |
Medtronic InFuse Recombinant Human Bone Morphogenetic
Protein in Cervical Spine Fusion AL09-13 |
| February 19, 2009 | Advisory
|
Cardinal Health’s Alaris System Infusion Pumps AD09-07 |
| January 13, 2009 | Alert
|
Product Recall: Duragesic® 50 mcg/h (Fentanyl Transdermal System) CII (patch)
National Drug code (NDC) 50458-034-05, Lot # 0817239 AL09-08 Amended 3/10/2009 |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
| December 30 , 2008 | Advisory |
Suicide attempt in the Emergency Room (ER) AD09-05 |
| December 22 , 2008 | Alert |
Improper set-up and reprocessing of flexible endoscope tubing and accessories AL09-07 |
| November 20, 2008 | Alert |
Maxi Move patient lifts with "Lock and Load" system (Combi Hanger): Manufactured by Arjo between November 2005 and April 2008 AL09-06 |
| October 27, 2008 | Alert |
Baxter Single Strength Dosing Card for BREVIBLOC Premixed Injection (esmolol HCl) 2,500 mg/250 mL (10 mg/mL) Ready-to-use-Bags, 250 mL bags AL09-03 |
| October 24, 2008 | Alert |
Medtronic Neuromodulation Sutureless Connector Catheters used with SynchroMed and IsoMed implantable infusion pumps:
|
| October 21, 2008 | Advisory |
Methicillin-resistant Staphylococcus aureus (MRSA) contamination in an orthopedic clinic room AD09-03 |
| October 21, 2008 | Advisory |
Bleeding episodes during dialysis AD09-02 |
| October 10, 2008 | Alert |
Shower curtains in locked mental health units AL09-01 |
| March 31, 2008 | Alert |
Improper reprocessing of flexible endoscope biopsy valves |
| March 12, 2008 | Alert |
STERIS C1160 Universal Flexible Processing Trays used with the STERIS
System 1 Sterile Processing Systems AL08-11 |
| February 29, 2008 | Alert |
Expanded Recall of Baxter Heparin Products AL08-10 |
| February 19, 2008 | Alert |
Baxter - Allergic Reactions to Heparin Sodium AL08-09 |
| January 25, 2008 | Alert |
Implant orientation of Implantable Cardioverter Defibrillators (ICDs) and Cardiac
Resynchronization Therapy Devices (CRT-Ds) manufactured by Boston Scientific
Corporation’s Cardiac Rhythm Management Division, previously under the name
Guidant. AL08-07 |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
| December 21, 2007 | Alert |
FDA CLASS II recall of Boston Scientific Corporation's Cardiac Rhythm Management Division (previously called Guidant) Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). AL08-06 |
| December 7, 2007 | Advisory |
Positive displacement, needle-free intravascular connector valves AD08-01 |
| November 29, 2007 | Alert |
Model 8100 infusion pump modules shipped before September 27, 2007; a
component of the Alaris Medley infusion pump system, distributed by Cardinal
Health. AL08-04 |
| October 25, 2007 | Alert |
Sprint Fidelis® Defibrillation Leads, manufactured by Medtronic AL08-02 |
| October 23, 2007 | Alert |
Medtronic SynchroMed EL implantable infusion pump;
models: 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18,
8627L-18. AL08-01 |
| May 18, 2007 | Alert |
Shelhigh, Inc. implantable medical products AL07-08 |
| April 18, 2007 | Alert |
Boston Scientific Corporation's Cardiac Rhythm Management Division (previously
called Guidant) recall of Implantable Cardiac Defibrillators (ICDs) and Cardiac
Resynchronization Therapy Defibrillators (CRT-Ds). AL07-07 |
| February 16 , 2007 | Alert |
Privacy curtains in locked mental health wards AL07-04 Attachment 1 |
| February 14, 2007 | Advisory |
Daylight Savings Time (DST) changes AD07-04 |
| January 31, 2007 | Advisory |
Reprocessing of resectoscope system’s working elements AD07-03 |
| January 8, 2007 | Advisory |
Gemini PC series infusion pumps manufactured by Alaris,
formerly IMED AD07-01 |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
| August 30, 2006 | Alert |
All models of Alaris® SE infusion pumps - formerly the Signature
Edition® Infusion System. Alaris is a subsidiary of Cardinal Health, Inc. AL06-16 |
| August 24 , 2006 | Advisory |
Shutdown of Donor Referral Services (DRS) Tissue Harvesting Co by FDA AD06-06 |
| July 24, 2006 | Alert |
Sealed, lead-acid batteries for external defibrillators supplied by non-OEM (Original Equipment Manufacturer) or second source suppliers. Second source suppliers
include Alpha Source, Anybattery, R&D Batteries and Unipower, among others. AL06-15 |
| June 28, 2006 | Alert |
Boston Scientific/Guidant Recall AL06-14 |
| May 8 , 2006 | Advisory |
Oxygen Regulator Fires Resulting from Incorrect Use of CGA 870 Seals AD06-05 |
| April 6, 2006 | Alert |
Mix-up (wrong route of administration) of bladder irrigation with intravenous (IV) infusions AL06-12 |
| April 3, 2006 | Alert |
Transrectal ultrasound transducer assembly, Models 8808 and 8551, manufactured by B-K Medical Systems, Inc., Wilmington, MA AL06-11 |
| March 6, 2006 | Alert |
Alaris IV Tubing sets, including commonly used 72023E and 72033E sets, manufactured by Cardinal Health, Alaris Products |
February 8, 2006 |
Alert |
Cessation of Topical Spray Benzocaine Usage to Anesthetize the Surfaces of the Nasopharynx, Oropharynx, Laryngotracheal Region and Airway AL06-09 |
| January 10, 2006 | Advisory |
Ipump Pain Management System, APII Infusion Pump and PCAII Infusion Pump, manufactured by Baxter Healthcare Corporation. AD06-03 |
| January 9, 2006 | Alert |
Physician Advisory issued by Medtronic Inc. on the Sigma Series single and dual chamber pacemakers (SD203, SD303, SDR203, SDR303, SDR306, SVDD303, SS103, SS106, SS203, SS303, SSR203, SSR303, SSR306, SVVI103) AL06-08 |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
December 21, 2005 |
Alert |
Injector connector relays on patient tables manufactured by Philips Medical, table models AD5 and AD6 used with the Integris, Integris Allura and Allura Xper x-ray systems.) AL06-06 |
November 1, 2005 |
Alert | Heat maintainers for Stellant CT Injector Systems, manufactured by MEDRAD, Inc. Part numbers for the heat maintainers are 3007871, 3007872, 3009707 and 3009708. (Note: Part numbers for the Stellant injector systems are 3007301, 3010432, 3007300 and 3010091.) AL06-04 |
October 5, 2005 |
Alert | Olympus 180 series endoscopes and Steris Quick Connects AL06-01 |
June 22, 2005 |
Alert | Smiths Medical, Fast Flow Fluid Warmer Models 250, 500 and 1000 AL05-14 |
June 8, 2005 |
Alert | Guidant Model 1861 Ventak Prizm 2 DR, Implantable Cardioverter-Defibrillators (ICD) manufactured before November 2002 AL05-13 |
May 31, 2005 |
Alert | Blood Glucose Monitors (Glucometers), models OneTouch, Ultra, InDuo, and OneTouch FastTake manufactured by LifeScan, Inc. AL05-11 |
May 12, 2005 |
Alert | Laerdal CM-100 Heartstart Adapter Cables AL05-10 |
March 29, 2005 |
Alert | Enclosed Bed systems manufactured by Vail Products Inc, models: 500, 1000, and 2000. AL05-09 |
February 28, 2005 |
Alert | Louvered heating, ventilating and air conditioning (HVAC) grilles in locked Behavioral Health Units. AL05-06 |
January 12, 2005 |
Alert | Nellcor pulse oximeters, model 595 and limited quantities of models 395, 295 and 290 Nellcor 595 Alert |
January 10, 2005 |
Advisory | Depression Screening for Veteran Patients Recently Separated from Active Military Duty Depression Screening Advisory |
January 6, 2005 |
Alert | Fire Response and Planning Fire Response Alert |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
November 17, 2004 |
Alert | Automated External Defibrillators (AED) manufactured by Access Cardiosystems, Inc. -- failure to operate correctly Access AED Alert |
November 9, 2004 |
Advisory | Electro-magnetic Interference (EMI) from the use of two-way hand held radios/ walkie-talkies in close proximity to medical devices. EMI Advisory |
October 21, 2004 |
Advisory | ALARIS (IMED) Gemini Infusion Pumps Alaris Gemini Advisory |
August 12, 2004 |
Alert | Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Cannula FDA Class I Recall Shiley Tracheosoft Alert |
July 22, 2004 |
Alert | Boston Scientific Stent System Recall Boston Scientific Stent Recall Alert |
July 8, 2004 |
Advisory | Tubing separation of Edwards Lifesciences VAMP Plus® Disposable Pressure Transducers Monitoring Kits Edwards VAMP Transducer Advisory |
July 2, 2004 |
Alert | Failure of medical alarm systems using paging technology to notify clinical staff Alarm Paging Alert |
June 28, 2004 |
Alert | DeRoyal ReliaFlex™ Suction Canisters with Liners DeRoyal Suction Canister Alert |
June 2, 2004 |
Alert | Minor Surgery/Exam lights: CoolSpot™ and Outpatient® Fleximount™ Single Ceiling and Track Mount with Single Trolley manufactured by Burton Medical before August 2000. Burton Lights Alert |
May 19, 2004 |
Alert | Class I Recall of Medtronic MiniMed Paradigm® Quick-set® Plus Infusion Sets Medtronic MiniMed Insulin Set Alert |
April 28, 2004 |
Alert | Implantable Cardioverter Defibrillators (ICD) manufactured by Medtronic Medtronic ICD Alert |
April 28, 2004 |
Advisory | Drug File View from CPRS CPRS Drug File Advisory |
April 5, 2004 |
Alert | Oxygen Utility System Oxygen Utility System Alert |
March 19, 2004 |
Alert | Propharma Twice-A-Day Nasal Spray Recall Propharma Nasal Spray Alert |
February 13, 2004 |
Alert | Connectors for Sterilization of all Gastrointestinal Fiberoptic Endoscopes |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
November 7, 2003 |
Alert | Counterfeit PROLENE |
November 7, 2003 |
Alert | Roche Diagnostics Corp. CoaguChek PT Test Strips |
November 4, 2003 |
Alert | J&J Cordis CypherTM Sirolimus-Eluting Coronary Stent |
July 21, 2003 |
Alert | Soft Skin protective sleeve |
July 14, 2003 |
Alert | Power cords for Hill-Rom Century+ electric beds |
June 18, 2003 |
Alert | Decimal point display - Abbott APM II pump |
June 18, 2003 |
Alert | In-line air filter requirement for Abbott Pumps |
May 5, 2003 |
Alert | ACCU-CHEK® Glucose Test Strips |
March 18, 2003 |
Alert | Counterfeit Drugs labeled as PROCRIT® |
March 6, 2003 |
Advisory | Olympus EXERA Gastrointestinal Endoscopes |
February 19, 2003 |
Alert | Zoll AED, Public Access Defibrillator Urgent Device Correction for Zoll AED (Letter) |
January 7, 2003 |
Alert | Kendall Connection Tubing Sets |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
November 25, 2002 |
Alert | Power cords used with GE Dinamap Vital Signs Monitors |
November 19, 2002 |
Alert | 4341B Thoracentesis Catheters |
September 30, 2002 |
Advisory | Cochlear Implant Risk |
September 13, 2002 |
Alert | Blood Tubing for Dialysis Baxter Tubing Alert (includes both NCPS Alert and FDA News Release) |
July 22, 2002 |
Advisory | SSCOR Suction Pumps |
May 30, 2002 |
Alert | Philips Viridia Information Centers |
May 28, 2002 |
Advisory | ADDENDUM to Advisory for Allegiance Irrigation Kits |
May 14, 2002 |
Alert | Baxter Colleague Infusion Pumps |
March 8, 2002 |
Alert | Bronchoscopes Manufactured by Olympus America |
February 27, 2002 |
Advisory | Potential for incorrectly attaching Allegiance Irrigation Kit caps to Foley catheters |
January 23, 2002 |
Alert | Zoll M Series defibrillators and M Series Automated External Defibrillators |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
August 28, 2001 |
Advisory | Hemodialysis Catheters: Ash Split and Vaxcel |
August 15, 2001 |
Advisory | Risperidone oral medication syringe (pipette) |
July 24, 2001 |
Alert | GE Workstation Alert |
July 12, 2001 |
Alert | Bed Rail Entrapment For additional information see the 1995 FDA Alert |
February 5, 2001 |
Alert | Magnetic Resonance Imaging (MRI) systems |
| Date Issued | Alert or Advisory | Product - Device Clicking on an alert name will open it in a new window. |
|---|---|---|
January 3, 2000 |
Alert | Ventilators - All Makes/Models |