Reported Jul 17, 2013 · Terminated
Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous…
Baxter Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corp. · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- 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.
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Product as published 2C1008KPLots: 08M036, 08N041, 09A030, 09B044, 09C053, 09D018, 09E019, 09F005; *** 2C1009KPLots: 08M016, 08M035, 08M066, 09A010, 09A052, 09A065, 09A080, 09B038, 09B048, 09B060, 09B074, 09C03, 09C016, 09C044, 09C060, 09D011, 09D042, 09D049, 09D054, 09E021, 09E043, 09F002; *** 2C1063KPLots: 08K078, 08M014, 08M060, 08N022, 08N053, 08N074, 09A032, 09A057, 09B006, 09B014, 09C007, 09C017, 09C054, 09C077, 09D015, 09D041, 09E012,09E018, 09E022, 09E044; *** 2C1087KPLots: 08K074, 08M050, 08N051, 09A053, 09B063, 09C041, 09D044, 09E073; *** 2C1156KPLots: 08M063, 09C042 - Amount recalled
- 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
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
- PR
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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