Terminated

CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution.

FDA Recall Z-2474-2015 · Posted 2015-08-27

Recalling FirmBaxter Healthcare Corp.

Recall StatusTerminated

Product CodeKDJ

Date Initiated2013-02-25

Date Terminated2016-03-08

Product Quantity35,460 units

Reason for Recall

Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.

Firm Action

Baxter sent an IMPORTANT PRODUCT INFORMATION letters dated February 25, 2013 to affected customers via USPS. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached reply form and return it to Baxter by faxing it to 224-270-5457 of scanning the form and e-mailing it to [email protected]. For general questions about this communication can be answered by contacting The Center for One Baxter at 800-422-9837 (Monday - Friday, 8:00 AM - 5:00 PM CST). Clinical questions can be answered by calling Baxter's Renal Division Clinic Help line at 888-736-2543 x 2 (Monday - Friday, 8:00 AM - 5:00 PM CST).

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution - US: Nationwide + American Samoa + District of Columbia + Guam + Northern Mariana Islands + Puerto Rico; *** FOREIGN: Antigua, Argentina, Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Chile, Colombia, Cuba, Curacao, Dominican Republic, Ecuador, El Salvador, France (New Caledonia), Guatemala, Guyana, Honduras, Hong Kong, India, Indonesia, Jamaica, Japan, Macau, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Suriname, Taiwan, Thailand, Trinidad and Tobago, United Kingdom (Cayman Islands), Uruguay, Venezuela

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K882498EXTENDED LIFE CAPD TRANSFER SET 5C4444Baxter Healthcare Corp · 1988-07-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.