GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271
This recall has been terminated (originally issued July 20, 2004).
- Company
- Abbott Labs
- Recall Initiated
- May 11, 2004
- Posted
- July 20, 2004
- Terminated
- October 20, 2004
- Recall Number
- Z-1077-04
- Quantity
- 18,432 units
- Firm Location
- Morgan Hill, CA
- Official Source
- View on FDA website ↗
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).
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
Lot / Code Info
95-156-5H, 05-027-5H, 09-208-5H
Root Cause
Other
Action Taken
Recall initiated May 11, 2004. Letters were sent to consignees and wholesalers.