Recall Z-2165-2013— Baxa Corporation

Name: FDA recall Z-2165-2013
Creator: U.S. Food and Drug Administration
Published: 2013-08-22

Class II · Terminated

Class II FDA medical device recall by Baxa Corporation, initiated 2013-08-22, terminated 2016-08-19. It names one FDA 510(k) clearance: K900585. Product: Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.. Reason: Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date..

Recalling firm: Baxa Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-08-22
Terminated: 2016-08-19
Firm location: Englewood, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K900585 — TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMPBaxa Corp., Sub. of Cook Group, Inc.·cleared 1990-04-18

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

Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.

Reason for recall

Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer Lock, due to incorrect expiry date.

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