—#130774

Product

GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours. ..

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K060806
Affected lot / code info: List Numbers: 13086, 13087, 13088; Serial Numbers: All Serial Numbers

Why it was recalled

Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their doctors. Patients are obtaining access to these codes via website sponsors by downloading the GemStar User/Service Manual featured on the sponsors' websites. The GemStar User/Service Manual should be removed from these w

Root cause (FDA determination)

Other

Action the firm took

Hospira sent a letters dated March 19, 2013 to Internet website sponsors to request removal of the GemStar User/Service Manual from their websites as soon as possible. The Internet website sponsors were requested to return a confirmation form after removing the GemStar User Service Manual from their site. For questions call 224-212-2891.

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: Worldwide Distribution - US: Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Croatia, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Icelanofd, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, New Zealand, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom

Timeline

Recall initiated: 2013-03-19
Posted by FDA: 2014-11-24
Terminated: 2016-09-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130774. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.