MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Bax

FDA device recall Z-2471-2015 · posted 2015-08-27 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

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.

Action taken

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 fca@baxter.com. 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

Status

Terminated

Product code

KDJ

Quantity affected

260,244 units

Distribution

Worldwide Distribution - US: Nationwide + American Samoa + District of Columbia + Guam + Northern Mariana Islands + Puerto Rico; *** FOREIGN: Antigua, Argentina, Australia, Bahamas, Barbados, Bermuda,

Date initiated

2013-02-25

Date posted

2015-08-27

Date terminated

2016-03-08

Location

Deerfield, IL

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