Recall Z-1945-2014— Baxter Healthcare Corp.

Name: FDA recall Z-1945-2014
Creator: U.S. Food and Drug Administration
Published: 2013-07-08

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2013-07-08, terminated 2014-06-30. It names one FDA 510(k) clearance: K895631. Product: Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.. Reason: the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2013-07-08
Terminated: 2014-06-30
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K895631 — DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466Baxter Healthcare Corp·cleared 1990-01-29

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

Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.

Reason for recall

the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging.

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