GE Healthcare, LLC: 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.

Recall number

Z-2663-2011

Recalling firm

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.

Status

Terminated

Initiated

2011-03-04

Posted

2011-06-24

Terminated

2012-10-31

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.

Root cause

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

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

KZD

Firm FEI

2126677

Firm city

Waukesha

Firm state

WI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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