>

MEETINGS / EVENTS

RSS

January 23 - 25 2015, 12:00 AM - 12:00 AM

ASA PRACTICE MANAGEMENT 2015

February 07 - 08 2015, 12:00 AM - 12:00 AM

ASA Certificate in Business Administration 2015

June 26 - 28 2015, 12:00 AM - 12:00 AM

Annual Perioperative Surgical Home Summit

>

FDA MEDWATCH ALERTS

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

October 25, 2014

FDA MedWatch - Intravia Containers by Baxter: Recall - Particulate Matter

Summary:

FDA MedWatch Intravia Containers by Baxter Recall

October 20, 2014

Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter

Summary:

FDA Medwatch Alert 10-20-14

>

ASA FEATURED PRODUCT

Add this product to your shopping cart

Self-Education and Evaluation (SEE) Program

SKU: 30701-14CE

... Read more »

Single Copies, Member Price: $360

Symbios GOPump Elastomeric Infusion PumpKit: Class 1 Recall - Flow Restrictor Bead May Become Displaced from its Fitting

Monday, March 18, 2013

AUDIENCE: Biomedical Engineering, Pain Management, Risk Managers

ISSUE: Symbios Medical Products, LLC sent its customers an "URGENT MEDICAL DEVICE RECALL" notification letter detailing the reason for recall and products listed. The reason for the recall is that the flow restrictor bead may become displaced from its fitting which may permit solutions to flow at a higher rate than intended. This product may cause serious adverse health consequences, including death. These kits were distributed between Sept. 10, 2012 and Feb. 11, 2013.  Refer to the Recall Notice for a list of kit part numbers.

BACKGROUND: The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system using an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.

RECOMMENDATION: Customers are asked to: segregate recalled product, complete verification form, indicate returned products on verification form, obtain a returned goods authorization (RGA) number, and package the returned products. Refer to the Recall Notice for details. 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


Read the MedWatch safety alert, including links to the Recall notice, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm344352.htm

« Back to FDA Alerts and Recalls