—#102820

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.

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K063696
Affected lot / code info: Product Code: 2M8161, Serial Number 12020525CC

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: (USA) Nationwide Distribution including the state of Minnesota.

Timeline

Recall initiated: 2011-07-22
Posted by FDA: 2011-08-08
Terminated: 2012-02-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #102820. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.