Recall Z-2074-2014— Baxter Healthcare Corp.

Name: FDA recall Z-2074-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-17

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2014-06-17, terminated 2015-04-03. It names one FDA 510(k) clearance: K895631. Product: Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For dialysis.. Reason: Inadequate iodine and packaging related defects..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-06-17
Terminated: 2015-04-03
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, Baxter Healthcare Corporation. For dialysis.

Reason for recall

Inadequate iodine and packaging related defects.

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