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U.S. Department of Health and Human Services

Class 2 Device Recall Hospira

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 Class 2 Device Recall Hospirasee related information
Date Initiated by FirmMarch 19, 2013
Date PostedNovember 24, 2014
Recall Status1 Terminated 3 on September 09, 2016
Recall NumberZ-0421-2015
Recall Event ID 69505
510(K)NumberK060806 
Product Classification Pump, infusion - Product Code FRN
ProductGemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. 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. .
Code Information List Numbers: 13000, 13100, 13150; Serial Numbers: All Serial Numbers
Recalling Firm/
Manufacturer		 Hospira Inc.
275 N Field Dr
Lake Forest IL 60045-2579
For Additional Information ContactMr. Michael B. Johannesen
224-212-2891
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Other
ActionHospira 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.
Quantity in CommerceNot Applicable
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRN
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