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FDA MEDWATCH ALERTS

November 21, 2014

FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur

Summary:

FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

November 21, 2014

FDA MedWatch - Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled

Summary:

Highly Concentrated Potassium Chloride Injection 10 mEq per 100 mL by Baxter Recall Mislabeled

November 07, 2014

FDA MedWatch - Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator

Summary:

FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall

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FDA MedWatch - Smiths Medical Portex Low Dead Space Connector with Sideport, 3.5mm: Class I Recall- One Lot Mislabeled

Tuesday, June 17, 2014

AUDIENCE: Anesthesiology, Risk Manager

ISSUE: FDA notified health professionals of a class 1 recall of this product due to one lot of 3.0mm sized connectors, Lot #2553426, which were mislabeled in packages as 3.5mm. The affected products were distributed in November 2013.

BACKGROUND: The connector is used to attach the endotracheal tube to the patient breathing circuit for respiratory support.

RECOMMENDATION: On April 10, 2014, Smiths Medical sent an Urgent Medical Device Recall to all affected customers. Customers should examine their inventory, remove all affected products and returned the completed Response Form and affected products to Smith Medical. Customers with questions were instructed to contact Smiths Medical’s Customer Service Department at 1-800-258-5361

Read the MedWatch safety alert, including a link to the recall notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm401038.htm

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