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U.S. Department of Health and Human Services

Class 2 Device Recall Colleague CX Infusion Pump

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 Class 2 Recall
Colleague CX Infusion Pump
see related information
Date Posted August 08, 2011
Recall Status1 Terminated on February 14, 2012
Recall Number Z-2958-2011
Recall Event ID 59449
Premarket Notification
510(K) Number
K063696 
Product Classification Pump, Infusion - Product Code FRN
Product Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015. Product Code: 2M8161. Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
Code Information Product Code: 2M8161, Serial Number 12020525CC
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake, Illinois 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall
Baxter's Service Center tested and returned to the user the Colleague infusion pump that did not meet PSIG (Pounds-force per Square Inch) specifications
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Baxter Healthcare Corp. notified the consignee by telephoned on July 22, 2011, with the call documented per the approved call script. A follow-up "URGENT PRODUCT RECALL" notification was sent dated July 25, 2011, reiterating the telephone communication informing them that the COLLEAGUE pump may not have met certain PSIG (Pounds-force per Square Inch) specifications after testing by the Baxter Global Technical Service Center. Both forms of notification identified the affected product, problem description, hazard involved, and actions needed to be taken. The consignee was instructed to locate the device, remove it from service and return it to Baxter by contacting Baxter Global Technical Services at 1-800-843-7867 option 1, to obtain a prepaid UPS label and shipping box. Upon receipt of the returned unit, Baxter will perform the required testing and address any issues through repair or service. The notication instructs the consignee to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter as per the instructions provided. If the recalled product have been distributed to another facility, or if you are a dealers, wholesalers and distributors, the letter request that this communication be forward to the pump owner as appropriate. For any questions regarding this communication contact the Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central time.
Quantity in Commerce 1 unit
Distribution (USA) Nationwide Distribution including the state of Minnesota.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = BAXTERHEALTHCARE, INC.
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