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Class I Medical Device Recall: Symbios GOPump and GOBlock Kits

Wed, 06/12/2013 - 12:00am
U.S. Food & Drug Administration

Recall Class: Class I

Date Recall Initiated: June 6, 2013

Product(s):

  • Symbios GOPump in the GoPump Rapid Recovery System Kits
  • Symbios GOBlock Kits

Lot numbers: All lots of GOPumps in the GoPump Rapid Recovery System kits and GOBlock kits manufactured with flow control components before July 2012. Please see the chart below listing all the lot numbers.

Manufacturing and Distribution Dates: The affected products were manufactured before July 2012 and distributed from April 27, 2011 to April 30, 2013.

Use:
The Symbios GOPump Rapid Recovery System is a disposable local pain management system that consists of a small balloon that is inflated with a local anesthetic medication. The medication is delivered slowly through tubes from the balloon to the surgical site.

Recalling Firm:
Symbios Medical Products, LLC
7301 Georgetown Road, Suite 150
Indianapolis, Indiana 46268

Distributor:
B. Braun Medical Inc.
901 Marcon Blvd.
Allentown, Pennsylvania 18109

Reason for Recall:
The affected products may have excessively high flow rates. As a result, medications could be delivered too quickly from the balloon to the surgical site and cause patient toxicity due to the rapid influx of medication. This can lead to serious illness, including seizure, abnormal heart rhythms and death. Elderly patients and patients with low body mass are at high risk of these complications.

Public Contact: Customers who purchased the product from B. Braun Medical, Inc. should contact B. Braun Customer Support at 1-800 227-2862.

Customers who purchased this product directly from Symbios Medical Products, call 1-317-319-0398 from 8:00 AM to 4:00 PM Eastern Standard Time to obtain directions for returning the product.

FDA District: Detroit District Office

FDA Comments:
Customers who have purchased the affected devices were notified by letter dated May 10, 2013 about the problem. Follow-up letters were sent on May 14, 2013 and May 30, 2013 notifying customers of additional recalled lots. The letters included directions to quarantine the product in a secure location and complete and return a verification form included in the letter.

B.Braun issued a customer notification on May 14, 2013. This notification directed customers to complete an attached “Product Removal Acknowledgement Form” and return using the provided self-addressed stamped envelop or by fax at 1-610-849-1197.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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