Recall Z-0778-05 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Configuration Transfer Cable; an accessory for the Colleague Infusion pump, Product code 2M8155; Baxter Healthcare Corporation, Deerfield, IL
| Date | Apr 27, 2005 (initiated Mar 2, 2005) |
| Status | Terminated |
| Reason | The Configuration Tranfer Cable for the Colleague Infusion Pumps has incorrect thumb screws on it., not allowing firm connections of the cable to the pump to transfer data to the biomedical engineer's diagnostic device. |
| Root cause | Other |
| Action | Recall letters dated 3/2/05 were sent to all customers receiving Configuration Transfer Cables between June and November 2004. The letters were sent to the attention of the Biomedical Engineer, and informed them that the thumbscrews were not manufactured according to Baxter''s specifications and were too narrow to secure the cable to the pump. The accounts were requested to return their Configuration Transfer Cables for replacement. |
| Quantity | 404 cables |
| Distribution | Nationwide, and internationally to Brazil, Canada, Chile, China, Colombia, Hong Kong, Korea, New Zealand, Japan, Taiwan, Saudi Arabia and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.