Recall Z-2473-2015— Baxter Healthcare Corp.

Name: FDA recall Z-2473-2015
Creator: U.S. Food and Drug Administration
Published: 2013-02-25

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2013-02-25, terminated 2016-03-08. It names one FDA 510(k) clearance: K882498. Product: MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.. Reason: 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..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2013-02-25
Terminated: 2016-03-08
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K882498 — EXTENDED LIFE CAPD TRANSFER SET 5C4444Baxter Healthcare Corp·cleared 1988-07-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.