CLASS II Device recall · Reported 17 Jul 2013 · FDA Enforcement Report
Baxter's elastomeric infusion pumps are non-electronic recalled
Baxter Healthcare is recalling Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices, distributed nationwide in the US. The recall was initiated on 31 Jul 2009 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1677-2013
- FDA event ID
- 65577
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Jul 2009
- FDA classified
- 10 Jul 2013
- Reported
- 17 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Infusion Pumps
Timeline
| 31 Jul 2009 | Recall initiated by company | |
| 10 Jul 2013 | Classified by FDA | +1440 days |
| 17 Jul 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
*** 1) Product Code: 2C1008KP; Lots: 08M036, 08N041, 09A030, 09B044, 09C053, 09D018, 09E019, 09F005; *** 2) Product Code: 2C1009KP; Lots: 08M016, 08M035, 08M066, 09A010, 09A052, 09A065, 09A080, 09B038, 09B048, 09B060, 09B074, 09C03, 09C016, 09C044, 09C060, 09D011, 09D042, 09D049, 09D054, 09E021, 09E043, 09F002; *** 3) Product Code: 2C1063KP; Lots: 08K078, 08M014, 08M060, 08N022, 08N053, 08N074, 09A032, 09A057, 09B006, 09B014, 09C007, 09C017, 09C054, 09C077, 09D015, 09D041, 09E012,09E018, 09E022, 09E044; *** 4) Product Code: 2C1087KP; Lots: 08K074, 08M050, 08N051, 09A053, 09B063, 09C041, 09D044, 09E073; *** 5) Product Code: 2C1156KP; Lots: 08M063, 09C042
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 65577This product is part of a recall event; the main page for the event is Baxter's elastomeric infusion pumps are non-electronic recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Baxter's elastomeric infusion pumps are non-electronic recalled | Baxter Healthcare | Packaging Defects | Nationwide | |
| CLASS II | Baxter's elastomeric infusion pumps are non-electronic recalled | Baxter Healthcare | Packaging Defects | Nationwide |
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Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |