Spine Safety Notices

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- Cautionary Notice

May 11, 2020

Fresenius Kabi's Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.)

Source: FDA MedWatch

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Device- Cautionary Notice

Apr 23, 2020

B. Braun Medical Inc. Issues Voluntary Nationwide Recall of One (1) Lot of Ceftazidime for Injection USP and Dextrose Injection USP (50 mL), Duplex Container Due to Out-of-Specification Results for High Molecular Weight Polymers

Source: FDA MedWatch

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Drug- Warning

Apr 23, 2020

Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples

Source: FDA MedWatch

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Device- Cautionary Notice

Apr 01, 2020

CME America Recalls BodyGuard Infusion Pump System Due to Risk of Over-, and Under-infusion

Source: FDA MedWatch

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Device- Cautionary Notice

Mar 24, 2020

CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion

Source: FDA MedWatch

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Device- Cautionary Notice

Mar 11, 2020

Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps Due to Software and System Errors

Source: FDA MedWatch

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Drug- Warning

Mar 11, 2020

Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP 30mg/mL, 1mL Fill/2mL Vials Due to the Potential Presence of Small Particulates

Source: FDA MedWatch

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Device- Cautionary Notice

Feb 18, 2020

King Systems Issues Recall of King Vision Video Laryngoscope Video Adapter Size 1/2

Source: FDA MedWatch

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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

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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

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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

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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

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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

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Drug- Cautionary Notice

Dec 16, 2019

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

Source: FDA Med Watch

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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

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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

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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

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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

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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

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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

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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

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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

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