FDA Device

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

Hazard

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).

What You Should Do

Remedy

Recall initiated May 11, 2004. Letters were sent to consignees and wholesalers.

Products

GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271
Brand
Abbott Labs
UPC
95-156-5H, 05-027-5H, 09-208-5H

Units Affected

18,432 units