GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for
FDA device recall Z-2031-2014 · posted 2014-07-10 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- Reason for recall
- The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the "self-test" while powering up which will result in a Beeper Error ("code 10/001/000"). This Beeper Error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.
- Action taken
- Hospira sent an URGENT MEDICAL DEVICE RECALL letter dated January 31, 2014 was sent to all affected customers. The letter included instructions for customers to: 1) inform potential users of these devices of the notification, 2) if the beeper error occurs during power up, remove the device from service immediately, 3) report any beeper errors to Hospira by calling 800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CST) or e-mail ProductComplaintsPP@hospira.com, 4) complete the attached reply form and return it to the fax number of e-mail address on the form (even if there is no product in inventory), and 5) if the products were further distributed, notify those customers that received the products and ask them to contact Stericycle at 855-827-6578 (Monday - Friday, 8:00 AM - 5:00 PM EST) to receive a reply form. A subsequent letter was sent on February 18, 2014 that included a correction to the description of the error code generated when a beeper wire failure occurs. That letter included identical instructions as those found in the January 31, 2014 letter for recipients to follow.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 36,881 infusion pumps
- Distribution
- Worldwide Distribution - US: Nationwide in the state of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK,
- Date initiated
- 2014-01-31
- Date posted
- 2014-07-10
- Date terminated
- 2016-08-30
- Location
- Lake Forest, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 (K060806) | Hospira, Inc. | 2006-04-21 |