Recall Z-2627-2010 ยท FPA Set, Administration, Intravascular
Hospira Inc.
Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve and Y-Extension with Backcheck Valve-SL, Nonvented, 110 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list number 12640-01
| Date | Sep 29, 2010 (initiated Aug 12, 2010) |
| Status | Terminated |
| Reason | Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication. |
| Root cause | Nonconforming Material/Component |
| Action | Hospira issued Urgent Device Recall letters dated August 12, 2010 to Hospira's direct accounts, informing them of the potential for under delivery under low rate settings using the affected lots of pump sets. The accounts were instructed to examine their inventory for the affected product, quarantine it immediately, and complete the attached reply form indicating the amount of product being returned, faxing it to Stericycle at 1-877-523-9110. If they distributed the affected product further, they were instructed to sub-recall the product from their sub-accounts. Accounts may contact Hospira Cu |
| Quantity | 22,680 sets |
| Distribution | Worldwide Distribution: USA, (all states), and the countries of Canada, Costa Rica and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060806 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 Hospira, Inc., Apr 21, 2006 |