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U.S. Department of Health and Human Services

Class 2 Device Recall Infusable and Infusa Scan Single Patient Use Pressure Infusors

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 Class 2 Recall
Infusable and Infusa Scan Single Patient Use Pressure Infusors
see related information
Date Posted June 24, 2011
Recall Status1 Terminated on October 31, 2012
Recall Number Z-2663-2011
Recall Event ID 58442
Product Classification Infusor, Pressure, For I.V. Bags - Product Code KZD
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.
Code Information 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
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
For Additional Information Contact Ms. Gwen Braeger
262-548-2608
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Device Design
Action 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.
Quantity in Commerce 954,888 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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