• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall GemStar Docking Station

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 1 Recall
GemStar Docking Station
see related information
Date Posted May 01, 2014
Recall Status1 Open
Recall Number Z-1512-2014
Recall Event ID 67802
Premarket Notification
510(K) Number
K060806 
Product Classification Pump, Infusion - Product Code FRN
Product GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.
Code Information *** US DOCKING STATIONS *** List Numbers: 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-04-09. *** FOREIGN DOCKING STATIONS *** List Numbers: 13075-24-01, 13075-24-03, 13075-24-05, 13075-24-07, 13075-92-09.
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
For Additional Information Contact Hospira Global Complaint Management
800-441-4100
Manufacturer Reason
for Recall
There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when the Docking Station is used in conjunction with a GemStar Phase 3 pump (List 13000-XX, 13100-XX, or 13150-XX) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to the Docking Station, and 2) when either a
FDA Determined
Cause 2
DESIGN: Device Design
Action Hospira sent an URGENT MEDICAL DEVICE CORRECTION letter dated February 18, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter included the following instructions: 1) To avoid failure to power up, turn the pump on first, before connecting the pump with the docking station. This will prevent the failure to power up. 2) To mitigate the potential for an 11/003 error code, remove the External Battery Pack accessory (List 13073) from the Docking Station in conjunction with an External Battery Pack accessory (List 13073), this practice should not continue. Please contact Hospira to discuss an appropriate alternative. Additional instructions included: 1) Inform potential users within the recipient's organization of the notification. 2) Should the facility experience a failure to power up or an 11/003 error code, report the issue to Hospira by calling 1-800-441-4100 (Monday - Friday, 8:00 AM - 5:00 PM CT) or e-mail ProductComplaintsPP@hospira.com. 3) Compelte the attached reply form and return it to the fax number or e-mail address on the firm, even if there is no affected product in inventory. 4) If th products were further distributed, notify the accounts that received the products identified in the notification and ask them to contact Steriycle at 866-792-5451 (Monday - Friday, 8:00 AM - 5:00 PM ET) to receive a reply form. For questions regarding this recall call 800-441-4100.
Quantity in Commerce 26,765 docking stations total (6866 in US)
Distribution Worldwide Distribution - USA including 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, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Guam, Puerto Rico, and Internationally to Australia, Austria, Bahrain, Belgium, Canada, Chile, Egypt, France, Germany, Greece, Hong Kong, Italy, Jordan, Kuwait, Lebanon, Libya, Luxemburg, Netherlands, New Zealand, Oman, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.
-
-