Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medicatio

FDA device recall Z-1677-2013 · posted 2013-07-10 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

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

Action taken

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 bag, quarantine the device and call Baxter's Corporate Product Surveillance at 1-800-437-5176 for further instructions. Customers were asked to return the attached reply form via FAX to 1-847-270-5457. If customers further distributed the affected product they were instructed to forward the notification to other facilities. Customers with questions were instructed to call 1-800-933-0303. For questions regarding this recall call 224-270-4667.

Root cause

Equipment maintenance

Status

Terminated

Product code

MEB

Quantity affected

Code 2C1008KP: 56,400 units; Code 2C1009KP: 180,004 units; Code 2C1063KP: 154,937 units; Code 2C1087KP: 43,521 units; Code 2C1156KP: 7,908 units

Distribution

Worldwide Distribution - USA (nationwide), Puerto Rico and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Czech Republic, Denmark (including Faroe Islands),

Date initiated

2009-07-31

Date posted

2013-07-10

Date terminated

2016-03-08

Location

Deerfield, IL

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