Infusable and Infusa Scan Single Patient Use Pressure Infusors…

Date posted by the FDA

June 24, 2011

Status

Terminated

Filed by

GE Healthcare, LLC

Product

Infusable and Infusa Scan Single Patient Use Pressure Infusors; Vital Signs Inc. A pressure infusor for an IV bag is a device consisting of an inflatable cuff which is placed around and IV bag. When the device is inflated, it increases the pressure on the IV bag to assist the infusion of the fluid.

Reason

Infusable and InfusaScan Pressure Infusors may leak and not apply desired pressure to their IV solution bag and subsequently the rate of infusion may be inadequate.

Distribution pattern

Worldwide distribution: USA (nationwide) states including: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY; and countries of: Argentina, Australia, Chile, Colombia, Canada, Denmark, Dominican Republic, Finland, Germany, Greece, Hong Kong/Macao, India, Israel, Italy, Korea, Lebanon, Lativia, Mexico, Malaysia, Nicaragua, Netherlands, New Zealand, Paraguay, Philippines, Portugal Panama, Puerto Rico, Peru, Russia, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Taiwan, Turkey, United Kingdom, Uruguay, Venezuela, and Vietnam.

Quantity

954,888 units

Codes and lots

IN800012; IN80048; IN80020; IN900012; IN900048; IN900020; IN950006; IN950012 Lot numbers: For the year 2009- Lot Number 2449 to Lot number 3659 F0r the year 2010 - Lot Number 0010 to Lot number 3250

Recall started

March 4, 2011

Device type

Infusor, Pressure, For I.V. Bags

Root cause (FDA)

Device Design

What the company told customers

The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated February 25, 2011 with an attached return response form to its customers via Fed Ex. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) DO NOT use infusable or InfusaScan pressure infusors (listed lot numbers). 2) Isolate all affected product and contact Vital Signs Customer Service at +1-973-956-5300 to arrange for the return and replacement of the infusor. 3) If they have forwarded any of the affected product to any other healthcare institution, forward a copy of this letter to those institutions. 4)Return only unused product. In addition, the customers were instructed to ensure that all potential users in their facility were made aware of this safety notification and the recommended actions, and to complete and return the attached confirmation form via fax to +1-973-956-5440. Please contact your local GE Healthcare Service Representative if you have any questions or concerns regarding this notification. You may also contact GE Healthcare Call Center: United States or Canada: 800-437-1171 and Other countries: 262-896-2890.

Recall number

Z-2663-2011

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2663-2011. The agency record governs; check it and the company before acting.