FDA Recall
Terminated
GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271
Recall: Z-1077-04
·
Initiated May 11, 2004
Recall
- Recall Number
- Z-1077-04
- Event Number
- 29056
- Firm
- Abbott Labs
- FEI Number
- 3004072476
- Product Code
- FRN
- Status
- Terminated
- Root Cause
- Other
- Initiated
- May 11, 2004
- Posted
- July 20, 2004
- Terminated
- October 20, 2004
- Address
- 755 Jarvis Dr, Morgan Hill, CA, 95037-2810
Description
GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271
Reason
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).
Action
Recall initiated May 11, 2004. Letters were sent to consignees and wholesalers.
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
Quantity
18,432 units