Recall Z-1077-04 ยท FRN Pump, Infusion
Abbott Labs
GemStar I.V. Administration Pump Set with Orange Polyethylene-Lined Light Resistant Tubing, List Number: 13271
| Date | Jul 20, 2004 (initiated May 11, 2004) |
| Status | Terminated |
| 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). |
| Root cause | Other |
| Action | Recall initiated May 11, 2004. Letters were sent to consignees and wholesalers. |
| Quantity | 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, Bethesd |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.