Recall Z-0605-2016— Baxter Healthcare Corp.

Name: FDA recall Z-0605-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-30

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2015-11-30, terminated 2016-10-30. It names one FDA 510(k) clearance: K860272. Product: Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device.. Reason: Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-11-30
Terminated: 2016-10-30
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K860272 — SOLUTION ADMINISTRATION SETSTravenol Laboratories, S.A.·cleared 1986-03-18

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 Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a container into the patients vascular system through a vascular access device.

Reason for recall

Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.

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