Recall Z-1269-2015— Baxter Healthcare Corp.

Name: FDA recall Z-1269-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-22

Class II · Completed

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2015-01-22. It names one FDA 510(k) clearance: K895631. Product: MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.. Reason: Product may have separating or protruding sponges.

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Completed
Initiated: 2015-01-22
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

MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.

Reason for recall

Product may have separating or protruding sponges

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