• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

  • Print
  • Share
  • E-mail
-

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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. *** 1) Product Code: 2C4700K; Lot: 09A014 Class II 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. *** Note: This product was not sold in the United States. Code 2C4700K: 4,128 units Z-1679-2013
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. *** 1) Product Code: 2C1700KP; Lots: 09C013, 09D023; *** 2) Product Code: 2C1702KP; Lots: 08M005, 08M056, 08N055, 09A029, 09B008, 09B061, 09C015, 09D013, 09D043, 09D081, 09E041, 09E070 Class II 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. Code 2C1700KP: 7,128 units; Code 2C1702KP: 105,732 units Z-1678-2013
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. *** 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 Class II 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. 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 Z-1677-2013
-
-