Recall Z-1679-2013— Baxter Healthcare Corp.

Name: FDA recall Z-1679-2013
Creator: U.S. Food and Drug Administration
Published: 2009-07-31

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2009-07-31, terminated 2016-03-08. It names one FDA 510(k) clearance: K071222. Product: 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 (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.. 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.

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2009-07-31
Terminated: 2016-03-08
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K071222 — INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICESBaxter Healthcare Corp·cleared 2007-05-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.