Gemstar Pump Set with Convertible Pin, Latex-Free set with Attached Pressure-Activated Anti-Siphon Valve, Pump Yellow St
FDA device recall Z-2633-2010 · posted 2010-09-29 · Terminated
Recall details
- Recalling firm
- Hospira Inc.
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 71,016 sets
- Distribution
- Worldwide Distribution: USA, (all states), and the countries of Canada, Costa Rica and Taiwan.
- Date initiated
- 2010-08-12
- Date posted
- 2010-09-29
- Date terminated
- 2012-06-21
- Location
- Lake Forest, IL
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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 |