Spine Safety Alerts


The North American Spine Society is committed to quality patient care through promotion of patient safety and prevention of medical errors. NASS monitors government and other resources for patient safety-related notices that may be useful to members. This service is provided for information and education only.

Drug- Alert
Jan 27, 2020

FUSION IV Pharmaceuticals, Inc dba. AXIA Pharmaceutical Issues Voluntary Nationwide Recall of All Sterile Drug Products Within Expiry Due to A Lack of Assurance of Sterility

Source: FDA MedWatch

Device- Alert
Jan 24, 2020

Surgical Gowns and Packs by Cardinal Health: FDA Statement - Potential Quality Issues Affecting Some of its Level 3 Surgical Gowns and Accompanying PreSource Procedural Packs

Source: FDA MedWatch; Audience: Patient, Health Professional, Risk Manager

Device- Cautionary Notice
Dec 27, 2019

Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy

Source: FDA MedWatch

Drug- Alert
Dec 22, 2019

FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR) - When used with CNS depressants or in patients with lung problems

Source: FDA MedWatch

Device- Cautionary Notice
Dec 18, 2019

Medtronic Recalls SynchroMed II Implantable Drug Infusion Pump Due to the Potential Presence of Foreign Particles Inside the Pump Motor Assembly Which May Lead to a Pump Motor Stall

Source: FDA MedWatch

Drug- Cautionary Notice
Dec 16, 2019

Public Safety Alert Due to Marketing of Unapproved Stem Cell and Exosome Products

Source: FDA Med Watch

Drug- Warning
Dec 16, 2019

FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk

Source: FDA News Release

Drug- Cautionary Notice
Sep 27, 2019

Hospira, Inc., Issues A Voluntary Nationwide Recall for one lot of BACTERIOSTATIC WATER for Injection, USP, due to a Potential Lack of Sterility Assurance

Source: FDA MedWatch

Device- Cautionary Notice
Aug 26, 2019

Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library Due to a "Low Priority" "Keep Vein Open (KVO), End of Infusion" Alarm and Multiple Software Errors

Source: FDA MedWatch

Device- Cautionary Notice
Jul 24, 2019

Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion

Source: FDA MedWatch

Device- Cautionary Notice
Jul 24, 2019

Becton Dickinson (BD) Recalls Alaris Infusion Sets for the Alaris Pump Model 8100 Due to Potential for Tube Collapse that May Cause Unintended Delivery or Faster than Expected Delivery of Medication

Source: FDA MedWatch

Drug- Alert
Jun 24, 2019

Premier Pharmacy Labs Issues Voluntary Nationwide Recall of all Unexpired Sterile Drug Product Lots Due to Lack of Sterility Assurance

Source: FDA MedWatch

Drug- Alert
Jun 24, 2019

RXQ Compounding, LLC Issues Voluntary Nationwide Recall of All Sterile Products within Expiry and Voluntarily Cessation of Production Due to the Lack of Sterility Process Assurance

Source: FDA MedWatch

Drug- Cautionary Notice
Jun 10, 2019

Heritage Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) as a Result of a Sterility Test Failure

Source: FDA MedWatch

Drug- Warning
May 08, 2019

Sagent Pharmaceuticals Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP, 60mg/2mL (30mg per mL) Due to Lack of Sterility Assurance

Source: FDA MedWatch

Drug- Alert
Apr 25, 2019

Alvogen Inc. Issues Voluntary Nationwide Recall of Fentanyl Transdermal System Due to Product Mislabeling

Source: FDA MedWatch

Device- Alert
Apr 17, 2019

Brainlab AG Recalls Spine & Trauma 3D Navigation Due to Inaccurate Display That May Result in User Misinterpretation

Source: FDA MedWatch

Drug- Alert
Apr 16, 2019

FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering

Source: FDA MedWatch

Device- Alert
Feb 25, 2019

ICU Medical Recalls ChemoLock Vial Spike (20mm) Due to Risk of Detached Plastic Particles

Source: FDA Medwatch

Device- Warning
Feb 05, 2019

West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions

Source: FDA MedWatch

Device- Alert
Feb 04, 2019

Intravascular Air-in-Line and Air Embolism Risks Associated with Infusion Pumps, Fluid Warmers, and Rapid Infusers: FDA Safety Communication

Source: FDA Safety Communication

Drug- Cautionary Notice
Jan 24, 2019

Lupin Pharmaceuticals, Inc. Issues Voluntary Recall of Ceftriaxone for Injection USP, 250mg, 500mg, 1g and 2g

Source: FDA MedWatch

Drug- Cautionary Notice
Jan 16, 2019

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of Vecuronium Bromide for Injection Due to the Presence of Particulate Matter Identified as Glass

Source: FDA MedWatch

Drug- Warning
Jan 02, 2019

Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

Source: FDA MedWatch

Drug- Warning
Dec 19, 2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Source: FDA MedWatch

Device- Alert
Nov 29, 2018

Zimmer Biomet, Inc. Recalls Spinal Fusion and Long Bone Stimulators Due to Lack of Adequate Validation and Controls to Ensure Product Cleanliness

Source: FDA MedWatch

Drug- Warning
Nov 28, 2018

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Source: FDA MedWatch

Drug- Cautionary Notice
Nov 26, 2018

Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration

Source: FDA MedWatch

Drug- Alert
Nov 21, 2018

FDA alerts health care professionals and patients not to use sterile drug products from Pharm D Solutions

Source: FDA MedWatch

Drug- Cautionary Notice
Nov 19, 2018

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

Source: FDA News Release