Medical Device Recall: Z-0015-2013

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

Recall Action Class: N/A Date Initiated: 2012-09-07 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0015-2013.

Recall Res Number
Z-0015-2013
Recalling Firm / Manufacturer
Baxter Healthcare Corp. Rt.
FEI Number
1416980
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2012-09-07
Date Posted
2012-10-09
Date Terminated
2017-12-29
Product Code
FPA
Event Number
63059
Product Quantity
488,504 units
Product Description Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Reason for Recall Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.
Action Details Baxter Healthcare Corp. sent an Urgent Product Recall letter dated September 7, 2012, via first class mail to all affected customers, informing them of the problem with the ball-valve, and instructing them to discontinue use of the affected product and to contact Baxter for instructions to return the affected product.. The customers were also requested to complete the attached customer reply form, confirming their receipt of the letter, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Medical Information Services at Baxter at 1-800-933-0303.
Distribution Pattern Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.
Code Information / Serial Numbers product code 2H8819, all lots

Related Establishments / Registrations

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