Recall Z-0421-2015
Hospira Inc. · initiated March 19, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
GemStar 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. .
Codes / lots: List Numbers: 13000, 13100, 13150; Serial Numbers: All Serial Numbers
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: Other
Action taken
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.
Details
- Recall number
- Z-0421-2015
- Initiated
- March 19, 2013
- Posted by FDA
- November 24, 2014
- Terminated
- September 9, 2016
- Product code
- FRN – Pump, Infusion
- Quantity
- Not Applicable
- Distribution
- 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…
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0422-2015 Class II | GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain…Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar… | 03/19/2013Terminated |