Z-1678-2013Class II

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

Name: Z-1678-2013 Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver...
Creator: Baxter Healthcare Corp.
Published: 2009-07-31
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2009-07-31 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7... on 2009-07-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1678-2013
Classification: Class II
Status: Terminated
Initiated: 2009-07-31
Posted: 2013-07-10
Terminated: 2016-03-08
Recalling firm: Baxter Healthcare Corporation
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.
Product code: MEB Pump, Infusion, Elastomeric
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
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: Code 2C1700KP: 7,128 units; Code 2C1702KP: 105,732 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), Ecuador, Finland, France (including Martinique and Reunion Islands), Germany, Greece, Iceland, India, Ireland, Isreal, Italy, Luxemburg, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweded, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.
Product codes and lots: *** 1) Product Code: 2C1700KP; Lots: 09C013, 09D023; *** 2) Product Code: 2C1702KP; Lots: 08M005, 08M056, 08N055, 09A029, 09B008, 09B061, 09C015, 09D013, 09D043, 09D081, 09E041, 09E070

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1678-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1677-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-10
Z-1678-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-10
Z-1679-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-10

Product code MEB

K071222Class IIInfusor Sv and Lv Elastomeric Infusion DevicesBaxter Healthcare Corp / cleared 2007-05-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)