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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Product Detail

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.
Recall Number Z-1677-2013
Classification Class II
Code Info *** 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
Product Distributed Qty 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
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 were contained within the storage pouch provided and observed prior to patient use.

Event Detail

Event Id 65577
Product Type Devices
Status Ongoing
Recalling Firm Baxter Healthcare Corp.
City Deerfield
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-07-31
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.