Recall Z-2628-2010
Hospira Inc. · initiated August 12, 2010
Product
Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve, Yellow Striped Tubing-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 13261-01
Codes / lots: list number 13261-01, lot numbers 691805H, 670695H, 760665H and 772085H
Reason for recall
Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication.
FDA-determined cause: Nonconforming Material/Component
Action taken
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 Customer Care at 1-877-946-7747 or their Hospira Account Manager to obtain replacement product. For medical inquiries, the accounts were directed to contact Hospira Medical Communications at 1-800-615-0187. Customers may contact Stericycle, which is managing this recall, at 877-274-7163 for further information concerning this recall.
Details
- Recall number
- Z-2628-2010
- Initiated
- August 12, 2010
- Posted by FDA
- September 29, 2010
- Terminated
- June 21, 2012
- Product code
- FPA – Set, Administration, Intravascular
- Quantity
- 170,304 sets
- Distribution
- Worldwide Distribution: USA, (all states), and the countries of Canada, Costa Rica and Taiwan.
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2627-2010 | Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon…Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not… | 08/12/2010Terminated |
| Z-2629-2010 | Gemstar Pump Set-SL, Latex-Free Extension Set with Integral Pressure-Activated…Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not… | 08/12/2010Terminated |
| Z-2630-2010 | Gemstar Pump Set-SL, Latex-Free Set with Attached Pressure-Activated Anti-Siphon Valve…Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not… | 08/12/2010Terminated |
| Z-2631-2010 | Gemstar Pump Set, LifeShield Latex-Free Pump Set with Check Valve, Clave Ports, P.A.V.…Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not… | 08/12/2010Terminated |
| Z-2632-2010 | Gemstar Pump Set, LifeShield Latex-Free Pump Set with Orange Polyethylene-Lined Light…Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not… | 08/12/2010Terminated |
| Z-2633-2010 | Gemstar Pump Set with Convertible Pin, Latex-Free set with Attached Pressure-Activated…Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not… | 08/12/2010Terminated |