Recall Z-0392-2014— Baxter Healthcare Corp.

Name: FDA recall Z-0392-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-25

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2013-09-25, terminated 2014-07-22. It names one FDA 510(k) clearance: K973654. Product: Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.. Reason: Incomplete foil seal on one lot of sterile product..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2013-09-25
Terminated: 2014-07-22
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K973654 — VIAL-MATE RECONSTITUTION DEVICE (2B8071)Baxter Healthcare Corp·cleared 1997-10-24

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, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is reconstitution device labeled for use with 20 mm drug vials and 50mL, 100mL, and 250mL Single Pack Mini Bags.

Reason for recall

Incomplete foil seal on one lot of sterile product.

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