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Symbios Medical Products' PumpKit Slapped With Recall


3/19/2013 7:52:18 AM

March 19, 2013 -- Recall Class: Class I

Date Recall Initiated: Feb. 25, 2013

Product: GOPump Elastomeric Infusion PumpKit with and without accessories all containing Dual GOPump, part number 510076: One infusion pump comprising two 150 mL elastomeric reservoirs in which each connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer.

Trade Name: Symbios GOPump

The kit part number and lot number may be found on the outer kit box labeling.

If the pump has been removed from the outer kit box, the pump part and lot number may be found on the sterile barrier packaging. If the pump has been removed from the sterile barrier packaging, the pump lot number is the first eight digits of the serial number label, found on the base of the pump.

These kits were distributed between Sept. 10, 2012 and Feb. 11, 2013.

Use: 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.

Recalling Firm:

Symbios Medical Products, LLC

7301 Georgetown Rd., Suite 150

Indianapolis, Indiana 46268

Distributor:

B. Braun Medical Inc.

901 Marcon Blvd.

Allentown, Pennsylvania 18109

Reason for Recall: 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.

Public Contact: See below under FDA Comments.

FDA District: Detroit District Office

FDA Comments:

On Feb. 25, 2013, the firm sent its customers an "URGENT MEDICAL DEVICE RECALL" notification letter detailing the reason for recall and products listed. The firm asked its customers to follow all the "Steps for Voluntary Field Action."

Segregate Recalled Product. Immediately remove all GOPump kits listed in the table above from your inventory (regardless of its location) and segregate this product in a secure location for return to Symbios Medical Products.

Complete Verification Form. Complete and return the enclosed Verification Form (even if you don’t have any products to return), following the direction on the page of the notification letter and the Verification Form. Your Symbios sales representative can assist you in completing the form.

Indicate Returned Products on Verification Form. The verification form lists the GOPump kit part number and lot number. Mark the number of GOPump kits that you are returning on the form.

Call 317-450-0145 from 7:00 AM to 5:00 PM Eastern Standard Time to Obtain a Returned Goods Authorization (RGA) Number. Your Symbios account will be credited in an amount equal to the purchase price for the returned product. Inform the Returned Goods Specialist if you wish to order any replacement product (if applicable).

Package the Returned Products: Package the GOPumps in an appropriate shipping box and add the RGA number on the outside. Place a signed original copy of the Verification Form in the box, seal it, and send it immediately to Symbios Medical Products at 7301 Georgetown Rd, Suite 150, Indianapolis, Indiana, 46268.

Distributors: Call Symbios at the number provided above and forward the "URGENT MEDICAL DEVICE RECALL" notification letter to all your affected customers.

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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