Home / Recalls / Hospira Inc. / Z-0422-2015

Z-0422-2015 Class II Terminated

Recalled by Hospira Inc. — Lake Forest, IL

FDA device recall Z-0422-2015 was initiated by Hospira Inc. on Mar 19, 2013 and is designated Class II. 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… The recall status is terminated (terminated Sep 9, 2016). Affected quantity: Not Applicable.

Recall Details

Product Type: Devices
Report Date: Dec 3, 2014
Initiation Date: Mar 19, 2013
Termination Date: Sep 9, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Not Applicable

Product Description

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. ..

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

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

Code Information

List Numbers: 13086, 13087, 13088; Serial Numbers: All Serial Numbers

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0422-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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