Recall Z-1463-2012 ยท FRN Pump, Infusion
Hospira Inc.
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.
| Date | Apr 26, 2012 (initiated Mar 28, 2012) |
| Status | Terminated |
| Reason | 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 | 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: Hospira2627@stericycle.com. Contact Hospira Customer Care at 1-877-9 |
| Quantity | 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, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023062 | GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT Abbott Laboratories, Inc., Sep 30, 2002 |
| K042980 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE Hospira, Inc., Nov 17, 2004 |
| K051079 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY Hospicare, Inc., May 19, 2005 |
| K060806 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 Hospira, Inc., Apr 21, 2006 |
| K083019 | GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE Hospira, Inc., Oct 22, 2008 |