Z-2628-2010

Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve, Yellow Striped...

Name: Z-2628-2010 Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve, Yellow Striped...
Creator: Hospira Inc.
Published: 2010-08-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-08-12 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve, Yellow Striped Tubing-SL, Nonvented, 110 inch; Rx, sterile, 24... on 2010-08-12. The reason FDA records is "Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2628-2010
Status: Terminated
Initiated: 2010-08-12
Posted: 2010-09-29
Terminated: 2012-06-21
Recalling firm: Abbott Medical
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
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 170,304 sets
Distribution: Worldwide Distribution: USA, (all states), and the countries of Canada, Costa Rica and Taiwan.
Product codes and lots: list number 13261-01, lot numbers 691805H, 670695H, 760665H and 772085H

Product code FPA

K060806Class IIHospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model 13088Hospira, Inc. / cleared 2006-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)