Recall Z-1677-2013 ยท MEB Pump, Infusion, Elastomeric
Baxter Healthcare Corp.
Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (I
| Date | Jul 10, 2013 (initiated Jul 31, 2009) |
| Status | Terminated |
| Reason | There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage |
| Root cause | Equipment maintenance |
| Action | Baxter sent an "Important Product Information" notification dated July 31, 2009, with a follow-up "Important Product Information" notification mailed on March 5, 2010. The notifications informed customers of the potential issue, and included instructions to ensure that the winged Luer cap is tightly secured after filling and priming. Customers were also instructed to follow normal clinical practices to reduce contact with any leaking medication, and to store pumps with pre-dispensed medication in a sealed pouch. If customers noticed a leak they were instructed to place the pump in a plastic b |
| Quantity | Code 2C1008KP: 56,400 units; Code 2C1009KP: 180,004 units; Code 2C1063KP: 154,937 units; Code 2C1087KP: 43,521 units; Co |
| Distribution | Worldwide Distribution - USA (nationwide), Puerto Rico and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Czech Republic, Denmark (including Faroe Islands), Ecuador, Finland, France (including Martinique and Reunion Islands), Germany, Greece, Iceland, Indi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071222 | INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES Baxter Healthcare Corp, May 25, 2007 |