Medical Device Recall: Z-0001-2011

FDA Recalls dataset · Firm: Baxter Healthcare Corp. Rt. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2010-08-04 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0001-2011.

Recall Res Number
Z-0001-2011
Recalling Firm / Manufacturer
Baxter Healthcare Corp. Rt.
FEI Number
1416980
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2010-08-04
Date Posted
2010-10-12
Date Terminated
2012-11-26
Product Code
FRN
Event Number
56425
Product Quantity
221,097 pumps
Product Description Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Reason for Recall The FDA sent a letter to Baxter on April 30, 2010, ordering the company to recall and destroy all models of its Colleague Volumetric Infusion Pumps currently in use in the United States. FDA determined that this action is necessary, as Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague pumps still in use. This recall is a consolidation of al
Action Details Baxter Healthcare Corporation sent "Urgent Product Recall" letters dated August 4, 2010 to all Colleague Infusion Pump customers in the U.S., to the attention of the Hospital Administrator, Chief Executive Officer, Chief Operating Officer, Chief Medical Officer and Chief Nursing Officer, referencing Baxter's May 3, 2010 announcement to recall all Colleague pumps from the U.S. market pursuant to an order under its existing consent decree with the FDA. The letters provided the customers with important information regarding the actions they must take prior to November 14, 2010 in order to continue using their Colleague pumps during the transition period. Customers were instructed to complete the attached Certificate of Medical Necessity Form and return it to Baxter as soon as possible, but no later than November 14, 2010, by scanning and e-mailing to Baxter at FCA@Baxter.com. Any questions were directed to their local Baxter Sales Representative or by calling the Center for One Baxter 1-800-422-9837, between 8AM and 5 PM Central Standard Time (CST). *** On July 20, 2011 Baxter sent recall letters to those Colleague customers who had not completed a decision form regarding the status and replacement of their Colleague Pumps. The accounts were asked to inform their Baxter sales representative as soon as possible of their pump decision, and to complete the attached customer reply form and return it to Baxter via fax or scanned e-mail. ***
Distribution Pattern Nationwide, including Puerto Rico
Code Information / Serial Numbers All product numbers and all serial numbers sold in the U.S.

Related Establishments / Registrations

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