Z-1463-2012

GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps...

Name: Z-1463-2012 GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps...
Creator: Hospira Inc.
Published: 2012-03-28
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-03-28 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; Hospira, Inc... on 2012-03-28. The reason FDA records is "Hospira has received customer reports of bolus delivery failures when using the GemStar bolus cord. Possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1463-2012
Status: Terminated
Initiated: 2012-03-28
Posted: 2012-04-26
Terminated: 2016-09-14
Recalling firm: Abbott Medical
Product: GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; Hospira, Inc., Lake Forest, IL 60045; List Number 13027; An accessory for the infusion pump that allows bolus requests to be made by a patient or clinician up to 6 feet (1.8 m) away from the pump.
Product code: FRN Pump, Infusion
Reason for recall: Hospira has received customer reports of bolus delivery failures when using the GemStar bolus cord. Possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the Bolus Cord.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Hospira, sent an "URGENT DEVICE FIELD CORRECTION RECALL" letter dated March 28, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The customers were instructed to take care when removing the bolus cord from the base of the GemStar unit, inspect the cord for damage, discontinue using any damaged cords, and to call Hospira at 1-800-241-4002 for replacement. A Reply Form was enclosed for customers to complete and return via fax to 1-866-912-7085 or e-mail to: [email protected]. Contact Hospira Customer Care at 1-877-946-7747 for technical assistance.
Quantity in commerce: 47,127 cords - U.S. and 39,968 cords - ROW
Distribution: Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Netherlands, New Zealand, Nola, Norway, Oman, Philippines, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay and Venezuela.
Product codes and lots: List Number 13027, all units

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)