Z-1077-04

GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271

Name: Z-1077-04 GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271
Creator: Abbott Labs
Published: 2004-05-11
License: https://open.fda.gov/license/

Abbott Labs / initiated 2004-05-11 / Terminated

FDA source

Abbott Labs began a recall of GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271 on 2004-05-11. The reason FDA records is "The firm's internal testing that revealed the potential air-in-line may go undetected when the set is used at temperatures above 25C (77 F)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1077-04
Status: Terminated
Initiated: 2004-05-11
Posted: 2004-07-20
Terminated: 2004-10-20
Recalling firm: Abbott Labs
Product: GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271
Product code: FRN Pump, Infusion
Reason for recall: The firm's internal testing that revealed the potential air-in-line may go undetected when the set is used at temperatures above 25C (77 F).
FDA root cause: Other
Action: Recall initiated May 11, 2004. Letters were sent to consignees and wholesalers.
Quantity in commerce: 18,432 units
Distribution: Total number of consignees that received product: 13. Five are wholesale dealers, None are distributors, 8 are retailers. Product has been distributed worldwide, and in the United States: AR, Washington DC, FL, IL, KY, LA, MA, MD, MN, MO, NJ, TX. Also sent to National Institute of Health, Bethesda, MD, (301) 496-4000
Product codes and lots: 95-156-5H, 05-027-5H, 09-208-5H

Product code FRN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)